The following data is part of a premarket notification filed by Laseroptek Co.ltd with the FDA for Pallas 308/311 Solid-state Uv Laser System.
| Device ID | K172639 |
| 510k Number | K172639 |
| Device Name: | PALLAS 308/311 Solid-State UV Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Laseroptek Co.Ltd #203 & #204 Hyundai 1 Valley 31 Galmachiro,Jungwon-Gu Gyeonggido, KP |
| Contact | Hong Chu |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-09-01 |
| Decision Date | 2017-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800035500313 | K172639 | 000 |