The following data is part of a premarket notification filed by Edge Systems, Inc. with the FDA for Del Sol Red Light Therapy System.
| Device ID | K072399 |
| 510k Number | K072399 |
| Device Name: | DEL SOL RED LIGHT THERAPY SYSTEM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | EDGE SYSTEMS, INC. 24372 MCCLOUD CT. Laguna Niguel, CA 92677 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik EDGE SYSTEMS, INC. 24372 MCCLOUD CT. Laguna Niguel, CA 92677 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-27 |
| Decision Date | 2008-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850043007340 | K072399 | 000 |