The following data is part of a premarket notification filed by Won Tech Co., Ltd. with the FDA for V-laser.
Device ID | K221427 |
510k Number | K221427 |
Device Name: | V-Laser |
Classification | Powered Laser Surgical Instrument |
Applicant | WON TECH Co., Ltd. 64 Techno 8-ro, Yuseong-Gu Daejeon, KR 34028 |
Contact | Hyun Sik Yoon |
Correspondent | Hyun Sik Yoon 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-05-16 |
Decision Date | 2022-08-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08800022304016 | K221427 | 000 |