The following data is part of a premarket notification filed by Won Tech Co., Ltd. with the FDA for Picocare.
| Device ID | K162755 |
| 510k Number | K162755 |
| Device Name: | Picocare |
| Classification | Powered Laser Surgical Instrument |
| Applicant | WON TECH CO., LTD. 64, Techno 8-ro, Yuseong-gu Daejeon, KR 305-500 |
| Contact | James Hoon Lim |
| Correspondent | James Hoon Lim WON TECH 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 | 2016-09-30 |
| Decision Date | 2017-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800022303200 | K162755 | 000 |