# PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 61/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254199 |
| Device | PicoreMax (PicoreMax) |
| Applicant | BLUECORE COMPANY Co., Ltd. |
| Specialty / panel | General, Plastic Surgery |
| Product code | GEX |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-29 |
| Decision date | 2026-09-24 |
| Review time (days) | 269 |
| Third-party review | No |
| Applicant location | Yangsan, KR |

## Why this score
- A long 269-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 42 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=K254199). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.