The following data is part of a premarket notification filed by Won Tech Co., Ltd. with the FDA for Picocaremajesty.
| Device ID | K212127 |
| 510k Number | K212127 |
| Device Name: | Picocaremajesty |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Won Tech Co., Ltd. 64 Techno 8-ro Yuseong-gu, KR 34028 |
| Contact | Hyun Sik Yoon |
| Correspondent | Hyun Sik Yoon Won Tech Co., Ltd. 64 Techno 8-ro Yuseong-gu, KR 34028 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-07 |
| Decision Date | 2022-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800022305600 | K212127 | 000 |