Booth, Sun Tan
FDA product code LEJ · 72 cleared devices
Class 2
General, Plastic Surgery
- Regulation
- 21 CFR 878.4635
- Review panel
- SU
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1980-05-28 – 2023-02-15
LEJ
2023-02-15
LEJ
2022-07-01
Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline
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LEJ
2019-10-28
KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
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LEJ
2019-05-10
Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
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LEJ
2019-04-08
Ergoline Sunrise 7200 Hybrid Technology
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LEJ
2018-10-11
Ergoline Prestige 1600 Hybrid Performance
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LEJ
2018-09-10
ProSun sunlamp products, Luxura sunlamp products
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LEJ
2018-06-22
UV Lamps for Sunlamp Products
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LEJ
2018-06-22
FIJI SUN FLUORESCENT TANNING UNIT
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LEJ
2018-04-19
Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)
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LEJ
2018-02-14
Sunrise 6200, Sunrise 7200
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LEJ
2017-07-06
HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
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LEJ
2016-09-15
KBL Sunlamp Products (= Device Bundling name)
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LEJ
2016-09-01
IBL 5000 Tanning Booth
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LEJ
2016-05-20
Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy
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LEJ
2016-05-19
Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
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LEJ
2016-05-02
HEX tanning booth
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LEJ
2016-04-29
T-32;T-40;T-44;T-52;T-72;TT-50
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LEJ
2016-04-14
uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
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LEJ
2016-03-04
Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5
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LEJ
2016-03-01
3400E series; E5400 series; E6400 series; Sundazzler series
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LEJ
2016-02-25
High Pressure Tanning Lamps
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LEJ
2016-01-27
BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
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LEJ
2009-05-29
TANTHERA-T35
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LEJ
1994-09-06
HARPO SUNBED, SUN TANNING MACHINE
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LEJ
1994-08-15
ALPHA SOLAR SYSTEM TANNING BED
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LEJ
1994-07-22
ODYSSEY TAN 2000
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LEJ
1994-04-05
TAN AMERICA SUN UP
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LEJ
1994-03-18
CLEO TL80W PROFESSIONAL CLEO TL80W PROFESSIONAL R, CLEO TL100 W PROFESSIONAL
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LEJ
1994-02-22
SUNDASH
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LEJ
1994-01-24
ULTRAVIOLET LAMPS FOR TANNING
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LEJ
1993-12-17
ULTRABRONZ SERIES 800 (ECLIPSE) TANNING BED
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LEJ
1993-12-17
ULTRABRONZ SERIES 400 TANNING BED
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LEJ
1993-12-09
SUNBRONZE TANNING LAMPS
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LEJ
1993-12-09
FLUORESCENT T12 UVA TANNING LAMP
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LEJ
1990-12-28
EUROSUN MODELS - ES-2400, ES-VHO AND ES-16
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LEJ
1990-06-27
LIFESTYLE HOME TANNING UNITS
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LEJ
1990-01-03
SUNBRONZE SB24C/65 ULTRA
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LEJ
1989-10-20
REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER
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LEJ
1989-09-15
SUNTANNING BED
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LEJ
1988-06-22
SHAW SUN SYSTEMS MODEL 1600
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LEJ
1988-04-19
MTI WOLFF SYSTEM, TANNING BED
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LEJ
1988-04-19
SUN SHELL (SUN TANNING BED)
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LEJ
1988-04-06
MTI WOLFF SYSTEM
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LEJ
1988-01-14
ULTRA TAN PURPLE PRO
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LEJ
1988-01-14
ULTRA TAN PURPLE MINT
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LEJ
1987-10-29
PERFECT SUNTANNING BED
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LEJ
1981-12-31
K60 HABITAT ENVIRONMENT ENCLOSURE
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LEJ
1981-12-31
K51,K52 ENVIRONMENT ENCLOSURE
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LEJ
1981-03-05
FANCY TAN SUNBED
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LEJ
1981-01-28
SUNSCENE TANNING STUDIO
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LEJ
1981-01-22
SUNMAKER (SUN TANNING BED)
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LEJ
1981-01-22
SEMI-OVAL MODULAR SUNTANNING BOOTH
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LEJ
1981-01-13
SUN TANNING DEVICES
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LEJ
1980-12-01
SOLAR TONE
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LEJ
1980-10-23
JK INT'L, INC. SOLTRON UVA TANNING BED
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LEJ
1980-10-23
U.I. OCTOSON
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LEJ
1980-10-03
CABANNA TAN SUNLAMP
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LEJ
1980-09-16
RAMI TAN ULTRAVIOLET B BOOTH
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LEJ
1980-09-16
RAMI ULTRAVIOLET A BOOTH
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LEJ
1980-09-16
SUN ROOM TANNING BOOTH
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LEJ
1980-09-16
SUN VALLEY TANS
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LEJ
1980-08-20
SUNBED/SUNROOF OR SUNCOUCH/SUNSKY
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LEJ
1980-08-20
CLASSIC TAN TANNING BOOTH
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LEJ
1980-08-20
SOLAR PACIFIC UVA SUNLAMP DEVICE
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LEJ
1980-07-28
SUNSATION
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LEJ
1980-07-21
TAN YEAR ROUND SUN BED
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LEJ
1980-07-21
SUNBURST, SUN SYSTEMS OR BC2
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LEJ
1980-07-21
THE SUN BOOTH
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LEJ
1980-06-04
SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1
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LEJ
1980-05-30
WOLFF SYSTEM
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LEJ
1980-05-28
CLINICAL DATA SYSTEM (CAM) MODULE
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