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FDA 510(k) clearances and recalls: Ophthalmic devices

7 FDA 510(k) clearances and recalls: Ophthalmic devices are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Visco Vision, Inc. with 1. Data last updated 2026-11-03; each record links to its official source and a full report.

Data as of · Compiled by Zalwin from U.S. FDA openFDA

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)

7 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Visco Vision, Inc. (1). Each record links to a full report and the official source.

Last updated 2026-11-03. Source: U.S. FDA openFDA.

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Records
7
Most frequent
  1. Visco Vision, Inc. (1)
  2. Heidelberg Engineering GmbH (1)
  3. Carl Zeiss Meditec Cataract Technologies (1)
  4. Bausch + Lomb, Inc. (1)
  5. Topcon Corporation (1)

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What are the top FDA 510(k) clearances and recalls: Ophthalmic devices right now?

RecordSpecialtyTypeDate
OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens (K253875): 510(k) cleared for Visco Vision, Inc.Ophthalmic510(k)2026-10-23
ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbHOphthalmic510(k)2026-09-11
MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract TechnologiesOphthalmic510(k)2026-10-15
Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941): 510(k) cleared for Bausch + Lomb, Inc.Ophthalmic510(k)2026-10-16
SLIT LAMP SL-D4 (Type: LED) (K262637): 510(k) cleared for Topcon CorporationOphthalmic510(k)2026-09-18
Miru 1day UpSide (midafilcon A) (K262495): 510(k) cleared for Menicon Co, Ltd.Ophthalmic510(k)2026-09-17
KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu FactoryOphthalmic510(k)2026-09-11

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510(k) clearances (414) Class II device recalls (320) Class I device recalls (19) Class III device recalls (11)

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Radiology (56) Orthopedic (53) Cardiovascular (52) General & Plastic Surgery (44) Dental (32) Gastroenterology & Urology (27) Neurology (23) Microbiology (21) Clinical Chemistry (15) General Hospital (14) Anesthesiology (12) Obstetrics & Gynecology (9)

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Radiology devices: recent FDA 510(k) clearances (56) Orthopedic devices: recent FDA 510(k) clearances (53) Cardiovascular devices: recent FDA 510(k) clearances (52) General & Plastic Surgery devices: recent FDA 510(k) clearances (44) Dental devices: recent FDA 510(k) clearances (32) Gastroenterology & Urology devices: recent FDA 510(k) clearances (27) Neurology devices: recent FDA 510(k) clearances (23) Microbiology devices: recent FDA 510(k) clearances (21) Clinical Chemistry devices: recent FDA 510(k) clearances (15) General Hospital devices: recent FDA 510(k) clearances (14) Anesthesiology devices: recent FDA 510(k) clearances (12) Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9) Ophthalmic devices: recent FDA 510(k) clearances (7)

Frequently asked questions

How many FDA 510(k) clearances and recalls: Ophthalmic devices are listed?

7 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23.

Can I get alerts for Ophthalmic?

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

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