The following data is part of a premarket notification filed by Laseroptek Co., Ltd. with the FDA for Picolo Premium.
| Device ID | K212573 |
| 510k Number | K212573 |
| Device Name: | PicoLO Premium |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Laseroptek Co., Ltd. #203 & #204 Hyundai I Valley, 31, Galmachi-ro 244 Beon-gil, Jungwon-gu Seongnam-si, KR 13212 |
| Contact | Hong Chu |
| Correspondent | Do Hyun Kim BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul, KR 06210 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-16 |
| Decision Date | 2021-12-08 |