# Dental Diode Laser Device (Laser-Pen) (K261047): 510(k) cleared for Guilin Kevin Peter Technology Co., Ltd.

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

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261047 |
| Device | Dental Diode Laser Device (Laser-Pen) |
| Applicant | Guilin Kevin Peter Technology Co., Ltd. |
| Specialty / panel | General, Plastic Surgery |
| Product code | GEX |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-31 |
| Decision date | 2026-09-18 |
| Review time (days) | 171 |
| Third-party review | No |
| Applicant location | Guilin, CN |

## Why this score
- 171-day review, longer than typical.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261047). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.