Dermapal, Uva 50HZ, Uva 60HZ, Uvb Broad Band 50HZ, Uvb Broad Band 60HZ,UVB Narrow Band 50HZ, Uvb Narrow Band 60HZ
FDA 510(k) K022104 · Daavlin Distributing Co.
510(k) numberK022104
Submission
- Device name
- Dermapal, Uva 50HZ, Uva 60HZ, Uvb Broad Band 50HZ, Uvb Broad Band 60HZ,UVB Narrow Band 50HZ, Uvb Narrow Band 60HZ
- Applicant
- Daavlin Distributing Co.
Bryan, OH, US - Received
- June 28, 2002
- Decision date
- September 10, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|---|
| K254234 | Phototherapy System (DUV-COMBO)FTC · Traditional | Choyang Medics Co., Ltd. | 05/01/2026SE |
| 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 |
|---|---|---|
| K233811 | DT Controlled Phototherapy EquipmentFTC · Special | 12/13/2023SE |
| K230382 | 3 Series NeoLuxFTC · Special | 03/24/2023SE |
| K220840 | 1 Series Phototherapy EquipmentFTC · Special | 04/22/2022SE |
| K212510 | 7 Series Phototherapy DeviceFTC · Traditional | 11/04/2021SE |
| K210881 | M Series Phototherapy EquipmentFTC · Traditional | 06/22/2021SE |
| K182215 | ClearLink Controlled Phototherapy EquipmentFTC · Traditional | 10/29/2018SE |
| K153749 | 3 Series Phototherapy UnitFTC · Special | 06/30/2016SE |
| K151795 | ML24000 UVA-1 Phototherapy CabinetFTC · Special | 09/10/2015SE |
| K110912 | Smart Touch Uvtherapy Multiple MachineFTC · Traditional | 10/20/2011SE |
| K111172 | 4 Series Phototherapy Unit Model 4 SeriesFTC · Traditional | 08/29/2011SE |
Questions and answers
When was Dermapal, Uva 50HZ, Uva 60HZ, Uvb Broad Band 50HZ, Uvb Broad Band 60HZ,UVB Narrow Band 50HZ, Uvb Narrow Band 60HZ cleared by the FDA?
Dermapal, Uva 50HZ, Uva 60HZ, Uvb Broad Band 50HZ, Uvb Broad Band 60HZ,UVB Narrow Band 50HZ, Uvb Narrow Band 60HZ (K022104) received a 510(k) decision of Substantially Equivalent on September 10, 2002, 74 days after the submission was received.
What is the product code of K022104?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.