The following data is part of a premarket notification filed by Pharos Life Corporation with the FDA for Tanda Skincare System, Model: Ptscs.
| Device ID | K080591 |
| 510k Number | K080591 |
| Device Name: | TANDA SKINCARE SYSTEM, MODEL: PTSCS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PHAROS LIFE CORPORATION 11-380 JAMIESON PKWY Cambridge, CA N3c 4n4 |
| Contact | Phil Cuscuna |
| Correspondent | Phil Cuscuna PHAROS LIFE CORPORATION 11-380 JAMIESON PKWY Cambridge, CA N3c 4n4 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-03 |
| Decision Date | 2008-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20806248005180 | K080591 | 000 |
| 20806248004930 | K080591 | 000 |
| 00806248004929 | K080591 | 000 |