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 | K191501 |
| 510k Number | K191501 |
| Device Name: | PALLAS 308/311 Solid-State UV Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Laseroptek Co., Ltd. #116, #117, #203, #204 Hyundai I Valley, 31, Galmachi-ro, 244beon-gil, Jungwon-gu Gyeonggido, KR 13212 |
| Contact | Hong Chu |
| Correspondent | Paweena U-thainual MDR Solutions Co., Ltd. 1435 Kanchanapisek Rd., Bang Khae Nuea Bangkok, TH 10160 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-06 |
| Decision Date | 2020-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800035500979 | K191501 | 000 |
| 08800035500962 | K191501 | 000 |
| 08800035500955 | K191501 | 000 |
| 08800035500948 | K191501 | 000 |
| 08800035500917 | K191501 | 000 |
| 08800035500900 | K191501 | 000 |
| 00088000355931 | K191501 | 000 |
| 08800035501143 | K191501 | 000 |