The following data is part of a premarket notification filed by Laseroptek Co. Ltd. with the FDA for Helios Iii.
| Device ID | K152856 |
| 510k Number | K152856 |
| Device Name: | Helios III |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASEROPTEK CO. LTD. 204 HYNDAI I-VALLEY 223-12 SANGDAIWON, JUNGWON Sungnam-si, KR 462-714 |
| Contact | Hong Chu |
| Correspondent | Kevin Choi CONSULTANT 28 STAFFORD DRIVE West Windsor, NJ 08550 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-29 |
| Decision Date | 2016-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800035501129 | K152856 | 000 |
| 08800035500795 | K152856 | 000 |
| 08800035500801 | K152856 | 000 |
| 08800035500818 | K152856 | 000 |
| 08800035500825 | K152856 | 000 |
| 08800035500832 | K152856 | 000 |
| 08800035500849 | K152856 | 000 |
| 08800035500856 | K152856 | 000 |
| 08800035500863 | K152856 | 000 |
| 08800035500870 | K152856 | 000 |
| 08800035500740 | K152856 | 000 |