510(k) K022104
- Device
- 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.
- 510(k) number
- K022104
- Product code
- FTC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-09-10
- Date received
- 2002-06-28
- Regulation
- 878.4630
- Classification name
- Light, Ultraviolet, Dermatological
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHAD REYNOLDS
- Address
- 205 W. Bement St. Bryan OH US 43506 43506
FDA Registration Numbers#
- 3016746323
- 3006580954
- 3013229265
- 1528161
- 3008393409
- 1022129
- 3005205318
- 3011024620
- 1318319
- 9680413
- 3007699081
- 3023306694
- 3009736547
- 3002672225
- 3003882673
- 3014226003
- 3017406171
- 3004193926
- 3015060197
- 3008872264
- 3004374705
- 3008255748
- 3004167969
- 1526255
Source Documents#
Other 510(k) Records For Product Code FTC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254234 | Phototherapy System (DUV-COMBO) | Choyang Medics Co., Ltd. | 2026-05-01 |
| K253871 | Klär Lite (RCW-KL1000) | Radcliffe Watts, LLC | 2026-03-04 |
| K250425 | Ultraviolet Phototherapy Device | APK Technology Co., Ltd. | 2025-04-07 |
| K244022 | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) | Boston Aesthetics, Inc. | 2025-03-13 |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025-02-06 |
| K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) | Shanghai Sigma High-Tech Co., Ltd. | 2024-12-19 |
| K233811 | DT Controlled Phototherapy Equipment | Daavlin Distributing Co. | 2023-12-13 |
| K223882 | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) | Shenzhen Honpal Optoelectronic Technology Co., Ltd. | 2023-03-27 |
| K230382 | 3 Series NeoLux | Daavlin Distributing Co. | 2023-03-24 |
| K230076 | Enhanced AURORA™ Medical Diode System, and related accessories | Psoria-Shield, Inc. | 2023-03-08 |
| K220840 | 1 Series Phototherapy Equipment | Daavlin Distributing Co. | 2022-04-22 |
| K210004 | i8 Tanning Booth | Ultrasun International B.V. | 2021-12-10 |
| K212510 | 7 Series Phototherapy Device | Daavlin Distributing Co. | 2021-11-04 |
| K210881 | M Series Phototherapy Equipment | Daavlin Distributing Co. | 2021-06-22 |
| K202827 | 308nm Excimer UV-light Skin Therapy System | Shenzhen Gsd Tech Co., Ltd. | 2020-12-15 |
Legacy Summary#
summary
FDA Review#
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