The following data is part of a premarket notification filed by Global Usa Distribution, Llc. with the FDA for Skinclear Q-switched Nd:yag Laser.
| Device ID | K083272 |
| 510k Number | K083272 |
| Device Name: | SKINCLEAR Q-SWITCHED ND:YAG LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | GLOBAL USA DISTRIBUTION, LLC. 10723 AQUILA AV. S. Minneapolis, MN 55438 |
| Contact | Matt Makousky |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-11-06 |
| Decision Date | 2008-12-16 |
| Summary: | summary |