Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FTC — Predicate Candidate Screening
272 FDA 510(k) clearances under this product code; the 50 most recent screened below.
43 daysmedian FDA review time
160 days90th percentile
272clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254234 | Phototherapy System (DUV-COMBO) | Choyang Medics Co., Ltd. | 2026-05-01 | 123 | 0 |
| K253871 | Klär Lite (RCW-KL1000) | Radcliffe Watts, LLC | 2026-03-04 | 90 | 0 |
| K250425 | Ultraviolet Phototherapy Device | APK Technology Co., Ltd. | 2025-04-07 | 52 | 0 |
| K244022 | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy S | Boston Aesthetics, Inc. | 2025-03-13 | 76 | 0 |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-40 | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025-02-06 | 133 | 0 |
| K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ3 | Shanghai Sigma High-Tech Co., Ltd. | 2024-12-19 | 86 | 0 |
| K233811 | DT Controlled Phototherapy Equipment | Daavlin Distributing Co. | 2023-12-13 | 14 | 0 |
| K223882 | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB | Shenzhen Honpal Optoelectronic Technology Co., Ltd. | 2023-03-27 | 90 | 0 |
| K230382 | 3 Series NeoLux | Daavlin Distributing Co. | 2023-03-24 | 39 | 0 |
| K230076 | Enhanced AURORA™ Medical Diode System, and related accessori | Psoria-Shield, Inc. | 2023-03-08 | 57 | 0 |
| K220840 | 1 Series Phototherapy Equipment | Daavlin Distributing Co. | 2022-04-22 | 30 | 1 |
| K210004 | i8 Tanning Booth | Ultrasun International B.V. | 2021-12-10 | 340 | 0 |
| K212510 | 7 Series Phototherapy Device | Daavlin Distributing Co. | 2021-11-04 | 86 | 1 |
| K210881 | M Series Phototherapy Equipment | Daavlin Distributing Co. | 2021-06-22 | 89 | 1 |
| K202827 | 308nm Excimer UV-light Skin Therapy System | Shenzhen Gsd Tech Co., Ltd. | 2020-12-15 | 82 | 0 |
| K200971 | 308nm Excimer System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2020-12-15 | 246 | 0 |
| K192411 | Psoria-Shield AURORA | Psoria-Shield | 2020-07-02 | 302 | 0 |
| K192642 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | 2020-05-13 | 232 | 0 |
| K191571 | UV Radiation Treatment System | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2020-02-06 | 237 | 0 |
| K191086 | Exciplex | Clarteis | 2019-12-11 | 231 | 0 |
| K181805 | UV Phototherapy | Xuzhou Kernel Medical Equipment Co., Ltd. | 2019-01-11 | 189 | 0 |
| K182215 | ClearLink Controlled Phototherapy Equipment | Daavlin Distributing Company | 2018-10-29 | 75 | 1 |
| K172273 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | 2018-07-30 | 367 | 0 |
| K173436 | Luma Light System | Luma Therapeutics | 2018-01-30 | 88 | 0 |
| K171702 | Exciplex308nm | Clarteis | 2017-10-13 | 127 | 0 |
| K170489 | Skylit Phototherapy System | Skylit Medical | 2017-05-23 | 95 | 0 |
| K153749 | 3 Series Phototherapy Unit | Daavlin Distributing Company | 2016-06-30 | 184 | 0 |
| K151795 | ML24000 UVA-1 Phototherapy Cabinet | Daavlin Distributing Co. | 2015-09-10 | 70 | 0 |
| K150752 | GME ExSys 308 | Gme (German Medical Engineering) GmbH | 2015-07-31 | 130 | 0 |
| K150912 | Houva-NET Control System | National Biological Corporation | 2015-07-10 | 98 | 0 |
| K134009 | UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL | Medtek Lighting | 2014-10-15 | 289 | 0 |
| K132643 | UV PHOTOTHERAPY | Xuzhou Kernel Medical Equipment Co., Ltd. | 2014-01-30 | 157 | 0 |
| K130519 | PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS | Philips Lighting Company | 2013-12-24 | 300 | 0 |
| K111049 | MOBILE VERSA LIGHT | Medtek Lighting Corp | 2012-05-25 | 406 | 0 |
| K110912 | SMART TOUCH UVTHERAPY MULTIPLE MACHINE | Daavlin Distributing Co. | 2011-10-20 | 202 | 0 |
| K111172 | 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES | Daavlin Distributing Co. | 2011-08-29 | 125 | 0 |
| K103204 | SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT F | Solarc Systems, Inc. | 2011-04-27 | 177 | 0 |
| K103708 | ML24000 UVA-1 PHOTOTHERAPY UNIT | The Daavlin Distributing Company | 2011-02-22 | 64 | 0 |
| K103540 | PSORIA-LIGHT | Psoria-Shield, Inc. | 2011-02-10 | 70 | 0 |
| K100378 | 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERI | Daavlin Distributing Co. | 2010-04-28 | 71 | 0 |
| K091568 | LH-75 PHOTOTHERAPY SYSTEM | Lerner Medical Devices, Inc. | 2009-11-05 | 156 | 0 |
| K090097 | LH-75T PHOTOTHERAPY SYSTEM | Lerner Medical Devices, Inc. | 2009-02-26 | 42 | 0 |
| K082731 | ML24000 UVA-1 PHOTOTHERAPY CABINET | Daavlin Distributing Co. | 2008-12-17 | 90 | 0 |
| K073503 | VERSA LITE | Diomedics, Inc. | 2008-01-23 | 41 | 0 |
| K073587 | DERMAPAL WITH DIGITAL TIMER | Daavlin Distributing Co. | 2008-01-18 | 29 | 0 |
| K073066 | 308 DERMATOLOGICAL EXCIMER SYSTEM | Quantel Medical, Inc. | 2007-12-26 | 57 | 0 |
| K072035 | RESOLVE UVB PHOTOTHERAPY SYSTEM | Allux Medical | 2007-10-16 | 83 | 0 |
| K070934 | PANOSOL II TRU-BLU, MODEL UBL-417 | National Biological Corp. | 2007-05-22 | 49 | 0 |
| K063621 | 3 SERIES PHOTOTHERAPY CABINET | Daavlin Co. | 2007-01-17 | 43 | 0 |
| K061589 | SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT F | Solarc Systems, Inc. | 2006-08-04 | 57 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda