The following data is part of a premarket notification filed by Solarc Systems Inc. with the FDA for Solarc / Solrx E-series Ultraviolet Phototherapy Lamp Unit Family.
| Device ID | K103204 |
| 510k Number | K103204 |
| Device Name: | SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | SOLARC SYSTEMS INC. 1515 SNOW VALLEY ROAD Minesing,ontario, CA L0l 1y3 |
| Contact | Bruce Elliott |
| Correspondent | Bruce Elliott SOLARC SYSTEMS INC. 1515 SNOW VALLEY ROAD Minesing,ontario, CA L0l 1y3 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-01 |
| Decision Date | 2011-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B219E720MUVBNB230V0 | K103204 | 000 |
| B219E740AUVBNB230V0 | K103204 | 000 |
| B219E740MUVBNB0 | K103204 | 000 |
| B219E740MUVBNB230V0 | K103204 | 000 |
| B219E760AUVBNB0 | K103204 | 000 |
| B219E760AUVBNB230V0 | K103204 | 000 |
| B219E760MUVBNB0 | K103204 | 000 |
| B219E760MUVBNB230V0 | K103204 | 000 |
| B219E720AUVB0 | K103204 | 000 |
| B219E720AUVBNB0 | K103204 | 000 |
| B219E720AUVBNB230V0 | K103204 | 000 |
| B219E720MUVB0 | K103204 | 000 |
| B219E720MUVBNB0 | K103204 | 000 |
| B219E740AUVBNB0 | K103204 | 000 |