Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
FDA 510(k) clearance K223882 · decided 2023-03-27
Clearance details
- K-number
- K223882
- Device name
- Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
- Applicant
- Shenzhen Honpal Optoelectronic Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-12-27
- Decision date
- 2023-03-27
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FTC
- Device class
- 2
- Regulation number
- 878.4630
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Phototherapy System (DUV-COMBO) (K254234) | Choyang Medics Co., Ltd. | 2026-05-01 |
| Klär Lite (RCW-KL1000) (K253871) | Radcliffe Watts, LLC | 2026-03-04 |
| Ultraviolet Phototherapy Device (K250425) | APK Technology Co., Ltd. | 2025-04-07 |
| 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) (K244022) | Boston Aesthetics, Inc. | 2025-03-13 |
| 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) (K242977) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025-02-06 |
| UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) (K242908) | Shanghai Sigma High-Tech Co., Ltd. | 2024-12-19 |
| DT Controlled Phototherapy Equipment (K233811) | Daavlin Distributing Co. | 2023-12-13 |
| 3 Series NeoLux (K230382) | Daavlin Distributing Co. | 2023-03-24 |
| Enhanced AURORA™ Medical Diode System, and related accessories (K230076) | Psoria-Shield, Inc. | 2023-03-08 |
| 1 Series Phototherapy Equipment (K220840) | Daavlin Distributing Co. | 2022-04-22 |
| i8 Tanning Booth (K210004) | Ultrasun International B.V. | 2021-12-10 |
| 7 Series Phototherapy Device (K212510) | Daavlin Distributing Co. | 2021-11-04 |
Recalls involving this device
No recalls on record reference this clearance.