The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Clarity Ii Laser System.
| Device ID | K183566 |
| 510k Number | K183566 |
| Device Name: | CLARITY II Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Lutronic Corporation Lutronic Center, 219, Sowon-ro Deogyang-gu, Goyang-si, KR 410220 |
| Contact | James Childs |
| Correspondent | James Childs Lutronic Corporation Lutronic Center, 219, Sowon-ro Deogyang-gu, Goyang-si, KR 410220 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809447652474 | K183566 | 000 |
| 08809447652467 | K183566 | 000 |