The following data is part of a premarket notification filed by Solarc Systems, Inc. with the FDA for Solarc / Solrx Handheld Ultraviolet Phototherapy Lamp Unit Family.
| Device ID | K061589 |
| 510k Number | K061589 |
| Device Name: | SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | SOLARC SYSTEMS, INC. 12 PARKER COURT Barrie, Ontario, CA L4n 2a6 |
| Contact | Bruce Elliott |
| Correspondent | Bruce Elliott SOLARC SYSTEMS, INC. 12 PARKER COURT Barrie, Ontario, 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 | 2006-06-08 |
| Decision Date | 2006-08-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B219ARM1000 | K061589 | 000 |
| B219120UVBNB230V0 | K061589 | 000 |
| B219120UVBNB0 | K061589 | 000 |
| B219120UVB0 | K061589 | 000 |
| B219110UVBNB230V0 | K061589 | 000 |
| B219110UVBNB0 | K061589 | 000 |
| B219110UVB0 | K061589 | 000 |