The following data is part of a premarket notification filed by Photo Therapeutics Limited with the FDA for Omnilux Plus.
| Device ID | K043317 |
| 510k Number | K043317 |
| Device Name: | OMNILUX PLUS |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | PHOTO THERAPEUTICS LIMITED STATION HOUSE STAMFORD NEW ROAD Altrincham, Cheshire, GB Wa14 1ep |
| Contact | Steven G Hutson |
| Correspondent | Steven G Hutson PHOTO THERAPEUTICS LIMITED STATION HOUSE STAMFORD NEW ROAD Altrincham, Cheshire, GB Wa14 1ep |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-02 |
| Decision Date | 2005-03-15 |
| Summary: | summary |