# PicoPeak Picosecond Nd:Yag Laser System (Bella-9) (K262701): 510(k) cleared for Beijing Sea Heart International Science and Technologyco.Ltd

**Predicate Speed & CAPA Advisory Opportunity Score:** 42/100

| 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 |

## Why this score
- Fast 83-day review: this device is a strong predicate for similar products.
- Posted 14 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262701). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.