Light, Ultraviolet, Dermatological
General, Plastic Surgery · 21 CFR 878.4630
Recent MDR events
120 adverse event reports on file
- PHOTHERA 600Apr 2, 2026MalfunctionThe Daavlin Distributing Co.1526255-2026-00002
- PHOTHERA P600Mar 20, 2026InjuryThe Daavlin Distributing Co./photheraMW5185460
- DAAVLIN 7 SERIESMar 20, 2026InjuryThe Daavlin Distributing Co.1526255-2026-00001
- ZERIGO HANDHALD SYSTEM POWER DEVICEFeb 23, 2026InjuryZerigo Health3013229265-2026-00001
- ZERIGO HEALTH UVB SMART LIGHT THERAPY DEVICE AND MOBILEJan 5, 2026InjuryZerigo Health, Inc.MW5181737
- ZERIGO HANDHALD SYSTEM POWER DEVICEDec 19, 2025InjuryZerigo Handhald System Power Device3013229265-2025-00001
- DAAVLIN PHOTO THERAPY MACHINEDec 11, 2025InjuryThe Daavlin Distributing Co.MW5180372
- ZERIGO UV LIGHT THERAPY DEVICEOct 31, 2025InjuryZerigo Health, Inc.MW5178357
- PHOTHERAJun 25, 2025InjuryThe Daavlin Distributing Co.MW5171945
- PHOTHERA 600-3D (PREVIOUSLY PANOSOL 6-3D) - FULL BODY, 8 LAMP/6FTJun 25, 2025InjuryThe Daavlin Distributing Co.MW5171948
Event type breakdown
Recalls
15 recall events for this product code
- Daavlin Distributing CompanyOpen, ClassifiedJul 15, 2026
Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Z-2742-2026 · View FDA record ↗ - Daavlin Distributing CompanyOpen, ClassifiedJul 15, 2026
Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Z-2743-2026 · View FDA record ↗ - Daavlin Distributing CompanyOpen, ClassifiedJul 15, 2026
Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Z-2744-2026 · View FDA record ↗ - Daavlin Distributing CompanyOpen, ClassifiedJun 2, 2026
Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (
Some of the Calibration/Output Certificates had the outputs reversed.
Z-2295-2026 · View FDA record ↗ - National Biological CorpTerminatedMar 20, 2017
Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment.
The wiring may allow the lamps to turn on with the key switch rather than the timer.
Z-1683-2017 · View FDA record ↗ - National Biological CorpTerminatedJul 19, 2013
Dermalight 80 Model Number UVB-080, one unit per box.
The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.
Z-1778-2013 · View FDA record ↗ - National Biological CorpTerminatedJul 19, 2013
Dermalight 80 Model Number UVB-083, one unit per box.
The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device.
Z-1779-2013 · View FDA record ↗ - National Biological CorpTerminatedAug 28, 2008
HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardboard boxes.
Software allows operator to override "low line voltage" error warning and store light intensity value.
Z-1309-2008 · View FDA record ↗ - Daavlin Distributing CompanyTerminatedJul 30, 2004
3 Series Full Body Phototherapy Device with Smart Touch Control System, Models #PASNBSM-2424.
Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved.
Z-1233-04 · View FDA record ↗ - Daavlin Distributing CompanyTerminatedJul 30, 2004
3 Series Full Body Phototherapy Device with Smart Touch Control System, Model All Touch Control System, Model #ASNBSM-2424 units manufactured between 6/5/03 an
Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved.
Z-1234-04 · View FDA record ↗
Registered firms
72 firms currently registered for this product code
The Daavlin Distributing Co.
Bryan, OH, US
Ultrasun
HENGELO Overijssel, NL
Medicol Usa, Inc
Snellville, GA, US
Shanghai Sigma High-tech Co., Ltd.
Shanghai, CN
Alma Lasers Ltd.
CAESAREA Northern, IL
Psoria-shield Inc
Utica, NY, US
Medtek Skin Care, Inc.
HUDSON FALLS, NY, US
Spectrum Assembly Inc.
Carlsbad, CA, US
Xuzhou Yongkang Electronic Science Technology Co., Ltd
Xuzhou Jiangsu, CN
German Medical Engineering Gmbh
Erlangen Bavaria, DE
Kbd, Inc.
North Las Vegas, NV, US
Apk Technology Co., Ltd
Shenzhen Guangdong, CN
Xuzhou Kernel Medical Equipment Co Ltd
Xuzhou Jiangsu, CN
Global Fabtech Wheel Chair (shanghai) Co., Ltd.
SHANGHAI, CN
Aerolase Corporation
Tarrytown, NY, US
Shenzhen Peninsula Medical Group
Shenzhen Guangdong, CN
510(k) clearances
272 clearances for this product code
- Choyang Medics Co., Ltd.May 1, 2026
K254234 · Phototherapy System (DUV-COMBO)
- Radcliffe Watts, LLCMar 4, 2026
K253871 · Klär Lite (RCW-KL1000)
- APK Technology Co., Ltd.Apr 7, 2025
K250425 · Ultraviolet Phototherapy Device
- Boston Aesthetics, Inc.Mar 13, 2025
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)
- Xuzhou Kernel Medical Equipment Co., Ltd.Feb 6, 2025
K242977 · 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
- Shanghai Sigma High-Tech Co., Ltd.Dec 19, 2024
K242908 · UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)
- Daavlin Distributing Co.Dec 13, 2023
K233811 · DT Controlled Phototherapy Equipment
- Shenzhen Honpal Optoelectronic Technology Co., Ltd.Mar 27, 2023
K223882 · Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)