Facial/Upper Body Unit
FDA 510(k) K851859 · Tannhut
510(k) numberK851859
Submission
- Device name
- Facial/Upper Body Unit
- Applicant
- Tannhut
Saratoga Springs, NY, US - Received
- April 26, 1985
- Decision date
- May 14, 1985
- 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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| K250425 | Ultraviolet Phototherapy DeviceFTC · Traditional | APK Technology Co., Ltd. | 04/07/2025SE |
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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 |
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| 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 |
|---|---|---|
| K851858 | Fold Away HutFTC · Traditional | 05/14/1985SE |
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| K840137 | Silgmann Solarium S-Type 1218 ComboFTC · Traditional | 04/23/1984SE |
| K837283 | Unknown · Traditional | 04/15/1983SE |
| K812579 | Suntanning Home UnitFTC · Traditional | 10/08/1981SE |
| K802756 | Semi-Oval Modular Suntanning BoothLEJ · Traditional | 01/22/1981SE |
Questions and answers
When was Facial/Upper Body Unit cleared by the FDA?
Facial/Upper Body Unit (K851859) received a 510(k) decision of Substantially Equivalent on May 14, 1985, 18 days after the submission was received.
What is the product code of K851859?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.