The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Action Ii Laser System.
| Device ID | K163196 |
| 510k Number | K163196 |
| Device Name: | ACTION II Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUTRONIC CORPORATION 219, SOWON-RO, HAENGSIN-DONG Deogyang-gu, Goyang-si, KR 410-722 |
| Contact | Jhung Won Vojir |
| Correspondent | Jhung Won Vojir LUTRONIC CORPORATION 6 NESHAMINY INTERPLEX, SUITE 100 Trevose, PA 19053 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-15 |
| Decision Date | 2017-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809447652160 | K163196 | 000 |