The following data is part of a premarket notification filed by Won Tech Co., Ltd. with the FDA for Holinwon 30.
| Device ID | K183563 |
| 510k Number | K183563 |
| Device Name: | Holinwon 30 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Won Tech Co., Ltd. 64 Techno 8-Ro, Yuseong-gu Daejeon, KR 34028 |
| Contact | Jake Yu |
| Correspondent | Jake Yu Won Tech Co., Ltd. 64 Techno 8-Ro, Yuseong-gu Daejeon, 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 | 2018-12-20 |
| Decision Date | 2019-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800022303309 | K183563 | 000 |