The following data is part of a premarket notification filed by Photo Therapeutics Limited with the FDA for Omnilux Red.
| Device ID | K030426 |
| 510k Number | K030426 |
| Device Name: | OMNILUX RED |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PHOTO THERAPEUTICS LIMITED 5 TIMBER LN. North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell PHOTO THERAPEUTICS LIMITED 5 TIMBER LN. North Reading, MA 01864 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-10 |
| Decision Date | 2003-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B434EM1258S0 | K030426 | 000 |