The following data is part of a premarket notification filed by Solarc Systems, Inc. with the FDA for Solarc 1000 Series Ultraviolet Phototherapy Lamp Unit.
| Device ID | K935572 |
| 510k Number | K935572 |
| Device Name: | SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | SOLARC SYSTEMS, INC. 12 PARKER COURT Barrie, Ontario, Canada, CA L4n 2a6 |
| Contact | Bruce Elliott |
| Correspondent | Bruce Elliott SOLARC SYSTEMS, INC. 12 PARKER COURT Barrie, Ontario, Canada, CA L4n 2a6 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1994-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B2191790UVBNB0 | K935572 | 000 |
| B2191780UVBNB230V0 | K935572 | 000 |
| B2191780UVBNB0 | K935572 | 000 |
| B2191760UVBNB0 | K935572 | 000 |
| B2191760UVB0 | K935572 | 000 |
| B2191740UVBNB0 | K935572 | 000 |
| B2191740UVB0 | K935572 | 000 |