PICO SHINING (PICO-K; PICOFY)— 510(k) K261214

Substantially Equivalent

Speclipse, Inc.

FDA 510(k) clearance K261214 for PICO SHINING (PICO-K; PICOFY), Substantially Equivalent on 2026-05-11. Applicant: Speclipse, Inc..

Clearance details

Applicant: Speclipse, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2026-04-14
Decision date: 2026-05-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

Adverse 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, 2020-01-01 through 2026-04-23. 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.