Data / Medical devices / Canada / Solarc Systems Inc.
Solarc Systems Inc.: FDA-registered device maker in MINESING Ontario, Canada, 4 510(k) clearances
Solarc Systems Inc. is registered with the FDA (registration 3004193926) in MINESING Ontario, Canada. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated April 27, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004193926
- Address
- 1515 Snow Valley Road, MINESING Ontario, Canada, L9X 1K3
- Owner or operator
- SOLARC SYSTEMS INC. (9014654)
- Roles
- Manufacturer
- First device listed
- November 8, 2007
- Registered through
- 2026
- Brand names listed
- Solarc/SolRx 100, 200 & 300 Series, Solarc/SolRx 1000 Series, Solarc/SolRx 500 Series, Solarc/SolRx E-Series
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light, Ultraviolet, Dermatological | FTC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 27, 2011 | K103204 | SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY | FTC | Substantially Equivalent | Solarc Systems, Inc. | accessdata.fda.gov |
| August 4, 2006 | K061589 | SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY | FTC | Substantially Equivalent | Solarc Systems, Inc. | accessdata.fda.gov |
| September 10, 2003 | K031800 | SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS: | FTC | Substantially Equivalent | Solarc Systems, Inc. | accessdata.fda.gov |
| March 7, 1994 | K935572 | SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT | FTC | Substantially Equivalent | Solarc Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 27, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.