DEVICE CLASS
Class II
REGULATION
21 CFR 878.4630
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES
Recent clearances
K254234Choyang Medics Co., Ltd. · 510k2026-05-01
K253871Radcliffe Watts, LLC · 510k2026-03-04
K250425APK Technology Co., Ltd. · 510k2025-04-07
K244022Boston Aesthetics, Inc. · 510k2025-03-13
K242977Xuzhou Kernel Medical Equipment Co., Ltd. · 510k2025-02-06
K242908Shanghai Sigma High-Tech Co., Ltd. · 510k2024-12-19
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.