The following data is part of a premarket notification filed by Laseroptek Co., Ltd. with the FDA for Helios Iv 785.
| Device ID | K212663 |
| 510k Number | K212663 |
| Device Name: | HELIOS IV 785 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-23 |
| Decision Date | 2022-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800035501532 | K212663 | 000 |
| 08800035501723 | K212663 | 000 |
| 08800035501716 | K212663 | 000 |
| 08800035501709 | K212663 | 000 |
| 08800035501693 | K212663 | 000 |
| 08800035501686 | K212663 | 000 |
| 08800035501679 | K212663 | 000 |
| 08800035501662 | K212663 | 000 |
| 08800035501655 | K212663 | 000 |
| 08800035501648 | K212663 | 000 |
| 08800035501631 | K212663 | 000 |
| 08800035501624 | K212663 | 000 |
| 08800035501549 | K212663 | 000 |
| 08800035501433 | K212663 | 000 |
| 08800035501525 | K212663 | 000 |
| 08800035501518 | K212663 | 000 |
| 08800035501501 | K212663 | 000 |
| 08800035501495 | K212663 | 000 |
| 08800035501488 | K212663 | 000 |
| 08800035501471 | K212663 | 000 |
| 08800035501464 | K212663 | 000 |
| 08800035501457 | K212663 | 000 |
| 08800035501440 | K212663 | 000 |
| 08800035501570 | K212663 | 000 |
| 08800035501587 | K212663 | 000 |
| 08800035501730 | K212663 | 000 |