The following data is part of a premarket notification filed by Snj Co., Ltd. with the FDA for Finebeam.
| Device ID | K202288 |
| 510k Number | K202288 |
| Device Name: | Finebeam |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SNJ Co., Ltd. No. 604, Ace-Techno Tower 2, Digital-ro 31-gil 19, Guro-gu Seoul, KR 08381 |
| Contact | Hyang-kee Lee |
| Correspondent | Jongrak Kim Med.com 2202 Gongwon-ro, Guro-gu Seoul, KR 08295 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-12 |
| Decision Date | 2021-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800086000015 | K202288 | 000 |
| 08800086000077 | K202288 | 000 |