The following data is part of a premarket notification filed by Ids, Ltd. with the FDA for Smaxel Co2 Surgical Laser System.
| Device ID | K180036 |
| 510k Number | K180036 |
| Device Name: | SMAXEL CO2 Surgical Laser System |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | IDS, LTD. 105, Byoksan Digital Valley 3 Cha, Digital-ro, Guro-gu Seoul, KR 08381 |
| Contact | Kwang Yeong Ahn |
| Correspondent | Alexander Braun Henderson BraunSolutions 970 South Dawson Way, Unit 14 Aurora, CO 80012 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-05 |
| Decision Date | 2018-02-02 |