The following data is part of a premarket notification filed by Global Usa Distribution, Llc. with the FDA for Skin Clear Srvh Long-pulsed Nd: Yag Laser.
| Device ID | K080697 |
| 510k Number | K080697 |
| Device Name: | SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | GLOBAL USA DISTRIBUTION, LLC. 9220 JAMES AVENUE SOUTH Minneapolis, MN 55431 |
| Contact | Ronald Berglund |
| 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 | 2008-03-12 |
| Decision Date | 2008-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800022300209 | K080697 | 000 |