The following data is part of a premarket notification filed by Solarc Systems, Inc. with the FDA for Solarc/solrx 500 Series Ultraviolet Phototherapy Lamp Unit Family A New Medical Device Family Consisting Of 5 Models:.
| Device ID | K031800 |
| 510k Number | K031800 |
| Device Name: | SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS: |
| 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 | 2003-06-11 |
| Decision Date | 2003-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B219550UVBNBCR0 | K031800 | 000 |
| B219550UVBNB230V0 | K031800 | 000 |
| B219550UVBNB0 | K031800 | 000 |
| B219550UVB0 | K031800 | 000 |
| B219540UVBNB0 | K031800 | 000 |
| B219530UVBNB0 | K031800 | 000 |
| B219520UVBNB0 | K031800 | 000 |