The following data is part of a premarket notification filed by Wontech Co., Ltd. with the FDA for V-laser.
| Device ID | K183156 |
| 510k Number | K183156 |
| Device Name: | V-Laser |
| Classification | Powered Laser Surgical Instrument |
| Applicant | WONTECH Co., Ltd. 64 Techno 8-Ro, Yuseong-Gu Daejeon, KR 305-500 |
| Contact | Erin Park |
| Correspondent | Erin Park WONTECH Co., Ltd. 64 Techno 8-Ro, Yuseong-Gu Daejeon, KR 305-500 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-15 |
| Decision Date | 2019-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800022304009 | K183156 | 000 |