The following data is part of a premarket notification filed by Ami Inc. with the FDA for Q-switched Nd:yag Laser System.
| Device ID | K172908 |
| 510k Number | K172908 |
| Device Name: | Q-Switched Nd:YAG Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AMI Inc. RM 1412, SJ Techno Ville, 287 Beotkkot-ro, Geumcheon-gu Seoul, KR 08511 |
| 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 | 2017-09-25 |
| Decision Date | 2017-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800042100001 | K172908 | 000 |