The following data is part of a premarket notification filed by Photo Therapeutics Limited with the FDA for Omnilux Revive And Omnilux Plus.
| Device ID | K050216 |
| 510k Number | K050216 |
| Device Name: | OMNILUX REVIVE AND OMNILUX PLUS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PHOTO THERAPEUTICS LIMITED STATION HOUSE STAMFORD NEW ROAD Altrincham, Cheshire, GB Wa14 1ep |
| Contact | Steve Hutson |
| Correspondent | Steve Hutson PHOTO THERAPEUTICS LIMITED STATION HOUSE STAMFORD NEW ROAD Altrincham, Cheshire, GB Wa14 1ep |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-31 |
| Decision Date | 2005-08-09 |
| Summary: | summary |