The following data is part of a premarket notification filed by Ami Inc. with the FDA for Fractional Co2 Surgical Laser System.
| Device ID | K173359 |
| 510k Number | K173359 |
| Device Name: | Fractional CO2 Surgical Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AMI Inc. RM. 1412, SJ Techno Ville, 278, Beotkkot-ro, Geumcheon-gu Seoul, KR 80511 |
| Contact | Hae Youn Lee |
| Correspondent | Alexander Braun Henderson BraunSolutions 970 South Dawson Way Unit 14 Aurora, CO 80012 -3827 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-26 |
| Decision Date | 2018-07-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800042100018 | K173359 | 000 |