- [Home](/) › - [FDAPulse](/v/fdapulse) › - [Hubs](/hub/fdapulse) › - General & Plastic Surgery # FDA 510(k) clearances and recalls: General & Plastic Surgery devices **44 FDA 510(k) clearances and recalls: General & Plastic Surgery devices are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Stryker Instruments with 2. Data last updated 2026-11-03; each record links to its official source and a full report.** Data as of 2026-11-03 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA Copy citation Download all 44 FDA 510(k) clearances and recalls: General & Plastic Surgery devices (CSV) — $4.99 → Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe [Free sample: 3 records (CSV)](/v1/verticals/fdapulse/records.csv?panel=General%2C%20Plastic%20Surgery) 44 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Stryker Instruments (2). Each record links to a full report and the official source. Last updated 2026-11-03. Source: U.S. FDA openFDA. **Search, filter and export FDAPulse records** [Run instant live search with these filters](/v/fdapulse?panel=General%2C%20Plastic%20Surgery&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/fdapulse/records.csv?panel=General%2C%20Plastic%20Surgery) Unlock the full CSV for these filters — $4.99 → ✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days ## Get new FDAPulse records by email (free, weekly) We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email. Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe. [See this week's digest](/digest/fdapulse) Records 44 Most frequent - Stryker Instruments (2) - Beijing Nubway S&T Co., Ltd. (2) - Shenzhen Dongdixin Technology Co., Ltd. (1) - Ezisurg Medical Co., Ltd. (1) - BLUECORE COMPANY Co., Ltd. (1) ## How do I get new FDA 510(k) clearances and recalls: General & Plastic Surgery devices by email? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/fdapulse?panel=General%2C%20Plastic%20Surgery) [Watch this exact filter](/v/fdapulse?panel=General%2C%20Plastic%20Surgery#more-ways) [See alert plans](/v/fdapulse#pricing) ## What are the top FDA 510(k) clearances and recalls: General & Plastic Surgery devices right now? | Record | Specialty | Type | Date | |---|---|---|---| | TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-10-13 | | easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges (K254291): 510(k) cleared for Ezisurg Medical Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-09-25 | | PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-09-24 | | Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223): 510(k) cleared for Bh Group Us, LLC | General, Plastic Surgery | 510(k) | 2026-09-22 | | Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O. | General, Plastic Surgery | 510(k) | 2026-09-19 | | SmartIPL_NI System (K241973): 510(k) cleared for Lumenis Be, Ltd. | General, Plastic Surgery | 510(k) | 2026-09-19 | | VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC | General, Plastic Surgery | 510(k) | 2026-09-18 | | MINT MONO Sutures (K254238): 510(k) cleared for Hans Biomed Corporation | General, Plastic Surgery | 510(k) | 2026-09-18 | | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC | General, Plastic Surgery | 510(k) | 2026-09-17 | | Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated | General, Plastic Surgery | 510(k) | 2026-09-11 | | Versius Surgical System (Versius Plus) (K261252): 510(k) cleared for Cmr Surgical Limited | General, Plastic Surgery | 510(k) | 2026-10-21 | | Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) (K261572): 510(k) cleared for Keyue (Hangzhou) Medical Information Technology Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-10-13 | | MeCare Alpha (MCA2019) (K260426): 510(k) cleared for IVT Medical, Ltd. | General, Plastic Surgery | 510(k) | 2026-10-08 | | Liora Monofilament Scaffold (K260474): 510(k) cleared for TELA Bio, Inc. | General, Plastic Surgery | 510(k) | 2026-09-28 | | ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319): 510(k) cleared for AtriCure, Inc. | General, Plastic Surgery | 510(k) | 2026-10-21 | | RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) (K261982): 510(k) cleared for Smith & Nephew Medical, Ltd. | Included in the full CSV with every column 🔒 Unlock all 44 records → | | Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752): 510(k) cleared for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | Included in the full CSV with every column 🔒 Unlock all 44 records → | | PicoPeak Picosecond Nd:Yag Laser System (Bella-9) (K262701): 510(k) cleared for Beijing Sea Heart International Science and Technologyco.Ltd | Included in the full CSV with every column 🔒 Unlock all 44 records → | Browse 29 more matching record reports - [RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) (K261982): 510(k) cleared for Smith & Nephew Medical, Ltd.](/report/fdapulse/renasys-abdo-shield-temporary-abdominal-closure-kit-gb--k261982) - [Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752): 510(k) cleared for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.](/report/fdapulse/facial-therapy-mask-z1-z2-z3-z5-z6-z7-z8-z9-k262752-cn--k262752) - [PicoPeak Picosecond Nd:Yag Laser System (Bella-9) (K262701): 510(k) cleared for Beijing Sea Heart International Science and Technologyco.Ltd](/report/fdapulse/picopeak-picosecond-nd-cn--k262701) - [Dental Diode Laser Device (Laser-Pen) (K261047): 510(k) cleared for Guilin Kevin Peter Technology Co., Ltd.](/report/fdapulse/dental-diode-laser-device-laser-pen-k261047-cn--k261047) - [Vessel Closure Device (VCD177213P) (K260677): 510(k) cleared for Vcd Medical S.R.L.](/report/fdapulse/vessel-closure-device-vcd177213p-k260677-it--k260677) - [LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated (K261070): 510(k) cleared for Covidien, LLC](/report/fdapulse/ligasure-ras-maryland-jaw-vessel-sealer-divider-nano-coated-co--k261070) - [Braun Aura 7 (6041) (K261975): 510(k) cleared for CyDen Limited](/report/fdapulse/braun-aura-7-6041-k261975-gb--k261975) - [Fast Absorbing PGLA (K263073): 510(k) cleared for Riverpoint Medical, LLC](/report/fdapulse/fast-absorbing-pgla-k263073-or--k263073) - [Braun Aura 9 (6042) (K261977): 510(k) cleared for Cyden Limited](/report/fdapulse/braun-aura-9-6042-k261977-gb--k261977) - [Picosecond Laser treatment system (Z180) (K262628): 510(k) cleared for Sanhe PERFECTLASER Technology Co., Ltd.](/report/fdapulse/picosecond-laser-treatment-system-z180-k262628-cn--k262628) - [SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000) (K262386): 510(k) cleared for Stryker Instruments](/report/fdapulse/safeair-electrosurgical-generator-with-smoke-evacuation-mi--k262386) - [AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3) (K262932): 510(k) cleared for Shenzhen Accompany Technology Co., Ltd.](/report/fdapulse/amiro-spectra-10-in-1-led-light-therapy-mask-l3-k262932-cn--k262932) - [Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) (K262443): 510(k) cleared for Sofradim Production](/report/fdapulse/transorb-self-gripping-resorbable-mesh-tsb1510-tsb2020-fr--k262443) - [KIM BLUE (K262284): 510(k) cleared for Desarrollo e Investigación Médica Aragonesa S.L.](/report/fdapulse/kim-blue-k262284-es--k262284) - [308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885): 510(k) cleared for Guangxi Hope Medical Devices Technology Co., Ltd.](/report/fdapulse/308nm-ultraviolet-light-therapy-device-xwyl-401a-xwyl-403a-cn--k262885) - [IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202) (K262352): 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd.](/report/fdapulse/ipl-hair-removal-device-ahr01-r3c16-g-pro1-ahr02-ahr03-cn--k262352) - [CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5) (K262346): 510(k) cleared for Wuhan Phomed Technology Co., Ltd](/report/fdapulse/curelight-medical-diode-laser-systems-s3-bf45-curelight-cn--k262346) - [Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401) (K262822): 510(k) cleared for Zhongshan GL Electronics Co. , Ltd.](/report/fdapulse/nasal-aspirator-tlc-n02-electric-nosefrida-pro-12300400-cn--k262822) - [Diode Laser Hair Removal Machine (QDTM-03) (K261692): 510(k) cleared for Beijing Nubway S&T Co., Ltd.](/report/fdapulse/diode-laser-hair-removal-machine-qdtm-03-k261692-cn--k261692) - [UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35) (K262285): 510(k) cleared for Shijiazhuang Recovery Star Medical Device Co., Ltd.](/report/fdapulse/uv-phototherapy-device-kzx-308nm-bl65-kzx-308nm-bl55-kzx-cn--k262285) - [Phasix ST Parastomal Hernia Mesh (K261543): 510(k) cleared for Davol, Inc., A Subsidiary of C.R. Bard, Inc.](/report/fdapulse/phasix-st-parastomal-hernia-mesh-k261543-ri--k261543) - [Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, R](/report/fdapulse/neptune-safeair-10ft-smoke-evacuation-pencil-square-coated-mi--k261959) - [SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (K262877): 510(k) cleared for Olympus Surgical Technologies America](/report/fdapulse/soltive-laser-system-soltive-pro-superpulsed-laser-soltive-ma--k262877) - [Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co., Ltd.](/report/fdapulse/sapphire-cooling-ipl-hair-removal-device-ice-2-0-ice-2-1-cn--k262524) - [LED Therapy Device (QLXY-01) (K261673): 510(k) cleared for Beijing Nubway S&T Co., Ltd.](/report/fdapulse/led-therapy-device-qlxy-01-k261673-cn--k261673) - [Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) (K261817): 510(k) cleared for Zhengzhou PZ Laser Slim Technology Co., Ltd.](/report/fdapulse/diode-laser-therapy-system-pz-bdt67-01-pz-bdt67-02-k261817-cn--k261817) - [Hygienic Protective Bite Cover (2207-010-50) (K262073): 510(k) cleared for Dürr Dental SE](/report/fdapulse/hygienic-protective-bite-cover-2207-010-50-k262073-de--k262073) - [GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) (K261467): 510(k) cleared for Gt Metabolic Solutions, Inc.](/report/fdapulse/gt-metabolic-magnet-system-mag-04-ds-01-gt-metabolic-magnet-mn--k261467) - [Safety lancet (XL) (K262526): 510(k) cleared for Tianjin Huahong Technology Co., Ltd.](/report/fdapulse/safety-lancet-xl-k262526-cn--k262526) [Browse all FDAPulse record reports](/hub/fdapulse/records) ## Which related categories and locations should I check? ### Browse by record type [510(k) clearances (414)](/hub/fdapulse/type/510k-clearances) [Class II device recalls (320)](/hub/fdapulse/type/class-ii-recalls) [Class I device recalls (19)](/hub/fdapulse/type/class-i-recalls) [Class III device recalls (11)](/hub/fdapulse/type/class-iii-recalls) ### Browse by specialty [Radiology (56)](/hub/fdapulse/specialty/radiology) [Orthopedic (53)](/hub/fdapulse/specialty/orthopedic) [Cardiovascular (52)](/hub/fdapulse/specialty/cardiovascular) [Dental (32)](/hub/fdapulse/specialty/dental) [Gastroenterology & Urology (27)](/hub/fdapulse/specialty/gastroenterology-urology) [Neurology (23)](/hub/fdapulse/specialty/neurology) [Microbiology (21)](/hub/fdapulse/specialty/microbiology) [Clinical Chemistry (15)](/hub/fdapulse/specialty/clinical-chemistry) [General Hospital (14)](/hub/fdapulse/specialty/general-hospital) [Anesthesiology (12)](/hub/fdapulse/specialty/anesthesiology) [Obstetrics & Gynecology (9)](/hub/fdapulse/specialty/obstetrics-gynecology) [Ophthalmic (7)](/hub/fdapulse/specialty/ophthalmic) ### Browse by record type by specialty [Radiology devices: recent FDA 510(k) clearances (56)](/hub/fdapulse/specialty_type/radiology--510k-clearances) [Orthopedic devices: recent FDA 510(k) clearances (53)](/hub/fdapulse/specialty_type/orthopedic--510k-clearances) [Cardiovascular devices: recent FDA 510(k) clearances (52)](/hub/fdapulse/specialty_type/cardiovascular--510k-clearances) [General & Plastic Surgery devices: recent FDA 510(k) clearances (44)](/hub/fdapulse/specialty_type/general-plastic-surgery--510k-clearances) [Dental devices: recent FDA 510(k) clearances (32)](/hub/fdapulse/specialty_type/dental--510k-clearances) [Gastroenterology & Urology devices: recent FDA 510(k) clearances (27)](/hub/fdapulse/specialty_type/gastroenterology-urology--510k-clearances) [Neurology devices: recent FDA 510(k) clearances (23)](/hub/fdapulse/specialty_type/neurology--510k-clearances) [Microbiology devices: recent FDA 510(k) clearances (21)](/hub/fdapulse/specialty_type/microbiology--510k-clearances) [Clinical Chemistry devices: recent FDA 510(k) clearances (15)](/hub/fdapulse/specialty_type/clinical-chemistry--510k-clearances) [General Hospital devices: recent FDA 510(k) clearances (14)](/hub/fdapulse/specialty_type/general-hospital--510k-clearances) [Anesthesiology devices: recent FDA 510(k) clearances (12)](/hub/fdapulse/specialty_type/anesthesiology--510k-clearances) [Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9)](/hub/fdapulse/specialty_type/obstetrics-gynecology--510k-clearances) [Ophthalmic devices: recent FDA 510(k) clearances (7)](/hub/fdapulse/specialty_type/ophthalmic--510k-clearances) ## Frequently asked questions ### How many FDA 510(k) clearances and recalls: General & Plastic Surgery devices are listed? 44 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23. ### Can I get alerts for General & Plastic Surgery? Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page. Source: U.S. FDA openFDA. Informational only. [RSS feed of new records](/feed/fdapulse.xml) ## Often used together - [NPIPulse](/v/npipulse) - [EPAPulse](/v/epapulse) - [Municipal Public Works Prime Contract Operating Permit Renewal Pulse](/v/pubworksregrenewpulse) - [TrialRecruitmentPageAudit](/trialrecruitmentpageaudit) - [SubdomainShadowPulse](/subdomainshadowpulse) - [MigrationSignalRadar](/migrationsignalradar) Or get the [Healthcare Vendor Bundle](/v/fdapulse#more-ways) for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.