Ultraviolet Treatment Lamps UV-8 & UV-9
FDA 510(k) K852534 · R. A. Fischer Co. Corp.
510(k) numberK852534
Submission
- Device name
- Ultraviolet Treatment Lamps UV-8 & UV-9
- Applicant
- R. A. Fischer Co. Corp.
Glendale, CA, US - Received
- June 14, 1985
- Decision date
- November 8, 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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Questions and answers
When was Ultraviolet Treatment Lamps UV-8 & UV-9 cleared by the FDA?
Ultraviolet Treatment Lamps UV-8 & UV-9 (K852534) received a 510(k) decision of Substantially Equivalent on November 8, 1985, 147 days after the submission was received.
What is the product code of K852534?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.