The following data is part of a premarket notification filed by Skincare Technology Inc. with the FDA for Revlight Skin Care System.
| Device ID | K042630 |
| 510k Number | K042630 |
| Device Name: | REVLIGHT SKIN CARE SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SKINCARE TECHNOLOGY INC. 70 W MADISON ST., SUITE 3300 Chicago, IL 60602 |
| Contact | Richard O Wood |
| Correspondent | Richard O Wood SKINCARE TECHNOLOGY INC. 70 W MADISON ST., SUITE 3300 Chicago, IL 60602 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-27 |
| Decision Date | 2005-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B82110300 | K042630 | 000 |
| B82110290 | K042630 | 000 |
| B82110000 | K042630 | 000 |