Ecumol Ultraviolet Suntannning Beds
FDA 510(k) K853177 · Mottek Intl. Corp.
510(k) numberK853177
Submission
- Device name
- Ecumol Ultraviolet Suntannning Beds
- Applicant
- Mottek Intl. Corp.
Scottsdale, AZ, US - Received
- July 30, 1985
- Decision date
- August 13, 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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| K253871 | Klär Lite (RCW-KL1000)FTC · Traditional | Radcliffe Watts, LLC | 03/04/2026SE |
| 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 |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…FTC · Traditional | Xuzhou Kernel Medical Equipment Co., Ltd. | 02/06/2025SE |
| 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 |
|---|---|---|
| K860198 | Model 7500/000 Kettler Holiday Solar Sun TanningFTC · Traditional | 02/18/1986SN |
| K855162 | Ultraviolet Sun Tanning Unit Kettler Holiday SolarFTC · Traditional | 02/12/1986SE |
| K854932 | Ecumol Ultraviolet Face Tanning UnitsFTC · Traditional | 01/30/1986SE |
| K853692 | Sun Tanning Bed Model EC-3RFFTC · Traditional | 10/01/1985SE |
| K852243 | Kettler Ultraviolet Suntanning Benches & LiftsFTC · Traditional | 06/27/1985SE |
| K852053 | Original Ultraviolet Suntanning LampFTC · Traditional | 05/20/1985SE |
| K843814 | Emumol Ultraviolet Suntanning LampFTC · Traditional | 10/25/1984SE |
| K802134 | JK Int'L, Inc. Soltron Uva Tanning BedLEJ · Traditional | 10/23/1980SE |
Questions and answers
When was Ecumol Ultraviolet Suntannning Beds cleared by the FDA?
Ecumol Ultraviolet Suntannning Beds (K853177) received a 510(k) decision of Substantially Equivalent on August 13, 1985, 14 days after the submission was received.
What is the product code of K853177?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.