The following data is part of a premarket notification filed by Laseroptek Co., Ltd. with the FDA for Picolo Nd:yag Picosecond Laser System.
| Device ID | K183392 |
| 510k Number | K183392 |
| Device Name: | PicoLO Nd:YAG Picosecond 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 Seongnam-si, KR 13212 |
| Contact | Hong Chu |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-12-07 |
| Decision Date | 2019-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800035500610 | K183392 | 000 |
| 08800035500634 | K183392 | 000 |
| 08800035500641 | K183392 | 000 |
| 08800035500658 | K183392 | 000 |
| 08800035500665 | K183392 | 000 |
| 08800035500672 | K183392 | 000 |
| 08800035500689 | K183392 | 000 |
| 08800035500696 | K183392 | 000 |
| 08800035500702 | K183392 | 000 |
| 08800035500771 | K183392 | 000 |
| 08800035501150 | K183392 | 000 |
| 08800035500986 | K183392 | 000 |
| 08800035500627 | K183392 | 000 |