PicoPeak Picosecond Nd:Yag Laser System (Bella-9) (K262701): 510(k) cleared for Beijing Sea Heart International Science and Technologyco.Ltd
PicoPeak Picosecond Nd:Yag Laser System (Bella-9) (K262701): 510(k) cleared for Beijing Sea Heart International Science and Technologyco.Ltd: 510(k) cleared for Beijing Sea Heart International Science and Technologyco.Ltd. Its amount of 83 is below the median of 138 (24th percentile). Dated 14 days ago, it is in the active follow-up window. Score 42/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 83 · 24th percentile of 414 FDAPulse records · 0.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262701 |
| Device | PicoPeak Picosecond Nd:Yag Laser System (Bella-9) |
| Applicant | Beijing Sea Heart International Science and Technologyco.Ltd |
| Specialty / panel | General, Plastic Surgery |
| Product code | GEX |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-31 |
| Decision date | 2026-10-22 |
| Review time (days) | 83 |
| Third-party review | No |
| Applicant location | Beijing, CN |
| amount percentile | 24th of 414 (median 138, 0.6x median) |
| Peer records CSV (76 CN records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-22
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (CN first): TECAR Therapy Device (TC2000, TC2001) (K252288) · BreathCare PAP III (YH-390N) (K260251) · Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K26023 · Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebuliz · Drainage Catheter (K254179) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: PicoPeak Picosecond Nd:Yag Laser System (Bella-9) (K262701): 510(k) cleared for Beijing Sea Heart International Science and Technologyco.Ltd and 76 CN peers
- CN FDAPulse records like this one: 76
- PicoPeak Picosecond Nd:Yag Laser System (Bella-9) (K262701): 510(k) cleared for Beijing Sea Heart International Science and Technologyco.Ltd's amount: 24th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 83-day review: this device is a strong predicate for similar products.
- Posted 14 days ago.
What is the FDAPulse record for PicoPeak Picosecond Nd:Yag Laser System (Bella-9) (K262701): 510(k) cleared for Beijing Sea Heart International Science and Technologyco.Ltd?
PicoPeak Picosecond Nd:Yag Laser System (Bella-9) (K262701) by Beijing Sea Heart International Science and Technologyco.Ltd was cleared on 2026-10-22 after 83 days of review.
How does PicoPeak Picosecond Nd:Yag Laser System (Bella-9) (K262701): 510(k) cleared for Beijing Sea Heart International Science and Technologyco.Ltd compare to other FDAPulse records?
Its amount of 83 is below the median (24th percentile); smaller records often move faster and face less competition. It is fresh: dated 14 days ago, inside the window where early outreach matters most.
PicoPeak Picosecond Nd vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| PicoPeak Picosecond Nd | CN | 2026-10-22 |
| TECAR Therapy Device (TC2000, TC2001) (K252288) | CN | 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) | CN | 2026-09-25 |
| Nd | CN | 2026-10-13 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: General & Plastic Surgery devices
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