Phototherapeutix Model 3200A
FDA 510(k) K935524 · Avex Industries , Ltd.
510(k) numberK935524
Submission
- Device name
- Phototherapeutix Model 3200A
- Applicant
- Avex Industries , Ltd.
Hudson Falls, NY, US - Received
- November 16, 1993
- Decision date
- February 17, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| K253871 | Klär Lite (RCW-KL1000)FTC · Traditional | Radcliffe Watts, LLC | 03/04/2026SE |
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| 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 |
|---|---|---|
| K935525 | Phototherapeutix Model 2480ABFTC · Traditional | 05/19/1995SE |
| K933954 | Phototherapeutix Model 2400BFTC · Traditional | 02/21/1995SE |
| K933953 | Phototherapeutix Model 1650BFTC · Traditional | 02/21/1995SE |
| K933952 | Phototherapeutix Model 800BFTC · Traditional | 02/21/1995SE |
| K935526 | Phototherapeutix Model 1600BFTC · Traditional | 02/17/1995SE |
Questions and answers
When was Phototherapeutix Model 3200A cleared by the FDA?
Phototherapeutix Model 3200A (K935524) received a 510(k) decision of Substantially Equivalent on February 17, 1995, 458 days after the submission was received.
What is the product code of K935524?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.