Ultrasun 4000 FT & 15000-8 Suntanning Unit
FDA 510(k) K860929 · Medical Device Consultants, Inc.
510(k) numberK860929
Submission
- Device name
- Ultrasun 4000 FT & 15000-8 Suntanning Unit
- Applicant
- Medical Device Consultants, Inc.
North Attleboro, MA, US - Received
- March 11, 1986
- Decision date
- March 28, 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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| 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 |
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| 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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| K860122 | Hemotec Act High Range Activated Clotting TimeJBP · Traditional | 04/04/1986SE |
| K860932 | Ultrasun 1000 & 2000 Suntanning UnitFTC · Traditional | 03/28/1986SE |
| K860931 | Ultrasun 3000 and 5000 Suntanning UnitFTC · Traditional | 03/28/1986SE |
| K860930 | Ultrasun 2500 Suntanning UnitFTC · Traditional | 03/28/1986SE |
Questions and answers
When was Ultrasun 4000 FT & 15000-8 Suntanning Unit cleared by the FDA?
Ultrasun 4000 FT & 15000-8 Suntanning Unit (K860929) received a 510(k) decision of Substantially Equivalent on March 28, 1986, 17 days after the submission was received.
What is the product code of K860929?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.