Solarc / Solrx E-Series Ultraviolet Phototherapy Lamp Unit Family
FDA 510(k) K103204 · Solarc Systems, Inc.
510(k) numberK103204
Submission
- Device name
- Solarc / Solrx E-Series Ultraviolet Phototherapy Lamp Unit Family
- Applicant
- Solarc Systems, Inc.
Minesing,Ontario, CA - Received
- November 1, 2010
- Decision date
- April 27, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTC – Light, Ultraviolet, Dermatological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4630
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FTC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254234 | Phototherapy System (DUV-COMBO)FTC · Traditional | Choyang Medics Co., Ltd. | 05/01/2026SE |
| K253871 | Klär Lite (RCW-KL1000)FTC · Traditional | Radcliffe Watts, LLC | 03/04/2026SE |
| K250425 | Ultraviolet Phototherapy DeviceFTC · Traditional | APK Technology Co., Ltd. | 04/07/2025SE |
| K244022 | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…FTC · Traditional | Boston Aesthetics, Inc. | 03/13/2025SE |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…FTC · Traditional | Xuzhou Kernel Medical Equipment Co., Ltd. | 02/06/2025SE |
| K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD…FTC · Traditional | Shanghai Sigma High-Tech Co., Ltd. | 12/19/2024SE |
| K233811 | DT Controlled Phototherapy EquipmentFTC · Special | Daavlin Distributing Co. | 12/13/2023SE |
| K223882 | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)FTC · Traditional | Shenzhen Honpal Optoelectronic Technology Co.… | 03/27/2023SE |
| K230382 | 3 Series NeoLuxFTC · Special | Daavlin Distributing Co. | 03/24/2023SE |
| K230076 | Enhanced AURORA Medical Diode System, and related accessoriesFTC · Traditional | Psoria-Shield, Inc. | 03/08/2023SE |
More from Psoria-Shield, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K061589 | Solarc / Solrx Handheld Ultraviolet Phototherapy Lamp Unit FamilyFTC · Traditional | 08/04/2006SE |
| K031800 | Solarc/Solrx 500 Series Ultraviolet Phototherapy Lamp Unit Family a New Medical Device…FTC · Traditional | 09/10/2003SE |
| K935572 | Solarc 1000 Series Ultraviolet Phototherapy Lamp UnitFTC · Traditional | 03/07/1994SE |
Questions and answers
When was Solarc / Solrx E-Series Ultraviolet Phototherapy Lamp Unit Family cleared by the FDA?
Solarc / Solrx E-Series Ultraviolet Phototherapy Lamp Unit Family (K103204) received a 510(k) decision of Substantially Equivalent on April 27, 2011, 177 days after the submission was received.
What is the product code of K103204?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.