The following data is part of a premarket notification filed by Global Usa Distribution, Llc. with the FDA for Laserpeel Soft-met Modified Erbium Laser.
| Device ID | K082028 |
| 510k Number | K082028 |
| Device Name: | LASERPEEL SOFT-MET MODIFIED ERBIUM 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 | 2008-07-17 |
| Decision Date | 2008-08-08 |
| Summary: | summary |