PicoreMax (PicoreMax)— 510(k) K254199
Substantially EquivalentBLUECORE COMPANY Co., Ltd.
FDA 510(k) clearance K254199 for PicoreMax (PicoreMax), Substantially Equivalent on 2026-09-24. Applicant: BLUECORE COMPANY Co., Ltd.. Device class: 2.
Summary
PicoreMax from BLUECORE COMPANY Co., Ltd. is filed under GEX, powered laser surgical instruments. The device name repeats itself in the record, and the record doesn't give the laser type, wavelength, or indications.
Class II, 21 CFR 878.4810. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
BLUECORE filed from Yangsan, South Korea. Review took 269 days (December 29, 2025 to September 24, 2026).
Clearance details
- Applicant
- BLUECORE COMPANY Co., Ltd.
- Product code
- Product code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yangsan, KR
Recent devices under product code GEX
view allMore clearances from BLUECORE COMPANY Co., Ltd.
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.