The following data is part of a premarket notification filed by Edge Systems Corporation with the FDA for Del Sol Blue Light Therapy System.
| Device ID | K061470 |
| 510k Number | K061470 |
| Device Name: | DEL SOL BLUE LIGHT THERAPY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | EDGE SYSTEMS CORPORATION 24372 MCCLOUD COURT Laguna Niguel, CA 92677 |
| Contact | Gary S Mocnik |
| Correspondent | Gary S Mocnik EDGE SYSTEMS CORPORATION 24372 MCCLOUD COURT Laguna Niguel, CA 92677 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-26 |
| Decision Date | 2006-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850043007364 | K061470 | 000 |
| 00850043007050 | K061470 | 000 |
| 00850043007036 | K061470 | 000 |
| 00850043007012 | K061470 | 000 |