Sunfit, Ultra Violet Lamps and Sunlamp Products
FDA 510(k) K861533 · Sunfit, Inc.
510(k) numberK861533
Submission
- Device name
- Sunfit, Ultra Violet Lamps and Sunlamp Products
- Applicant
- Sunfit, Inc.
New Rochelle, NY, US - Received
- April 24, 1986
- Decision date
- May 8, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
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Questions and answers
When was Sunfit, Ultra Violet Lamps and Sunlamp Products cleared by the FDA?
Sunfit, Ultra Violet Lamps and Sunlamp Products (K861533) received a 510(k) decision of Substantially Equivalent on May 8, 1986, 14 days after the submission was received.
What is the product code of K861533?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.