Product code FTC— General, Plastic Surgery
SUNLAMP
- Classification name
- Light, Ultraviolet, Dermatological
- Device class
- Class 2
- Regulation
- 21 CFR 878.4630
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 272
- First cleared
- Most recent
Market context for product code FTC
FDA has cleared devices under product code FTC between 1976 and 2026, filed by 150 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code FTC
Recent clearances under product code FTC
1–100 of 272- K254234 — Phototherapy System (DUV-COMBO)
- K253871 — Klär Lite (RCW-KL1000)
- K250425 — Ultraviolet Phototherapy Device
- K244022 — 308nm UV Phototherapy System (4 models)
- K242977 — 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
- K242908 — UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD) +1 more
- K233811 — DT Controlled Phototherapy Equipment
- K223882 — Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
- K230382 — 3 Series NeoLux
- K230076 — Enhanced AURORA Medical Diode System, and related accessories
- K220840 — 1 Series Phototherapy Equipment
- K210004 — i8 Tanning Booth
- K212510 — 7 Series Phototherapy Device
- K210881 — M Series Phototherapy Equipment
- K200971 — 308nm Excimer System
- K202827 — 308nm Excimer UV-light Skin Therapy System
- K192411 — Psoria-Shield AURORA
- K192642 — 308nm Excimer System
- K191571 — UV Radiation Treatment System
- K191086 — Exciplex
- K181805 — UV Phototherapy
- K182215 — ClearLink Controlled Phototherapy Equipment
- K172273 — 308nm Excimer System
- K173436 — Luma Light System
- K171702 — Exciplex308nm
- K170489 — Skylit Phototherapy System
- K153749 — 3 Series Phototherapy Unit
- K151795 — ML24000 UVA-1 Phototherapy Cabinet
- K150752 — GME ExSys 308
- K150912 — Houva-NET Control System
- K134009 — UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL
- K132643 — UV PHOTOTHERAPY
- K130519 — PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS
- K111049 — MOBILE VERSA LIGHT
- K110912 — SMART TOUCH UVTHERAPY MULTIPLE MACHINE
- K111172 — 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES
- K103204 — SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
- K103708 — ML24000 UVA-1 PHOTOTHERAPY UNIT
- K103540 — PSORIA-LIGHT
- K100378 — 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4
- K091568 — LH-75 PHOTOTHERAPY SYSTEM
- K090097 — LH-75T PHOTOTHERAPY SYSTEM
- K082731 — ML24000 UVA-1 PHOTOTHERAPY CABINET
- K073503 — VERSA LITE
- K073587 — DERMAPAL WITH DIGITAL TIMER
- K073066 — 308 DERMATOLOGICAL EXCIMER SYSTEM
- K072035 — RESOLVE UVB PHOTOTHERAPY SYSTEM
- K070934 — PANOSOL II TRU-BLU, MODEL UBL-417
- K063621 — 3 SERIES PHOTOTHERAPY CABINET
- K061589 — SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
- K061295 — VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
- K051330 — UVBIOTEK MODELS 3200B AND 4000B
- K052660 — MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO
- K050080 — CYNOSUREA ECLILITE AND ECLILITE U
- K050695 — FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT
- K042502 — 3 SERIES PHOTOTHERAPY CABINET
- K041212 — HOUVA 3 PHOTOTHERAPY SYSTEM
- K033946 — LOVELY SYSTEM
- K040062 — LEVIA PHOTOTHERAPY SYSTEM
- K031800 — SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS:
- K024020 — THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM
- K022104 — DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ
- K021762 — BCLEAR
- K022165 — THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2
- K020591 — BCLEAR
- K021092 — PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B
- K021514 — PHILIPS PLS9W/12/2P UVB
- K011197 — DERMACLEAR UV-B PHOTOTHERAPY SYSTEM
- K982082 — HANDISOL WOUND HEALING
- K935525 — PHOTOTHERAPEUTIX MODEL 2480AB
- K933952 — PHOTOTHERAPEUTIX MODEL 800B
- K933953 — PHOTOTHERAPEUTIX MODEL 1650B
- K933954 — PHOTOTHERAPEUTIX MODEL 2400B
- K935524 — PHOTOTHERAPEUTIX MODEL 3200A
- K935526 — PHOTOTHERAPEUTIX MODEL 1600B
- K935572 — SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT
- K935840 — TL 20W/12/RS & TL 40W/12/RS
- K934808 — UVISOL AND UVISOL II
- K933146 — ESB 2400 SEI
- K930856 — PSORALITE
- K924969 — PHOTOTHERAPY TIMER
- K925171 — FREE SUN PRO DESIGN 3000 AND 3800
- K924077 — HANDISOL
- K922963 — TL100W/12
- K915426 — MEDICAL SUNLAMP FOR PHOTOTHERAPY
- K913760 — PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT
- K910767 — TL100W/01 UVB LAMP
- K904426 — PANOSOL II UVA-218
- K904427 — PANOSOL II UVB-206
- K904428 — PANOSOL II UAB-228
- K904425 — MODEL 6/01 UV-B FIXTURE
- K901324 — U.V. SUNLAMP 95UF-II
- K900649 — FLUORESCENT T12 UVA LAMP
- K900693 — U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC)
- K896191 — SUNTANNING BED, INC. T12 UVA TANNING LAMPS
- K896831 — ALISUN SUNTANNING BED
- K895410 — REMINGTON TANFASTIC HANDHELD TANNING WAND
- K885026 — HOUVA II UVB
- K885029 — HOUVA II UVA/UVB
- K890084 — PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 45000
Data sourced from openFDA. This site is unofficial and independent of the FDA.