PERFECT SUNTANNING BED— 510(k) K873589

Name: FDA 510(k) clearance K873589
Creator: U.S. Food and Drug Administration
Published: 1987-10-29

Substantially Equivalent

Wolff System Technology Corp.

FDA 510(k) clearance K873589 for PERFECT SUNTANNING BED, Substantially Equivalent on 1987-10-29. Applicant: Wolff System Technology Corp.. Device class: 2.

Clearance details

Applicant: Wolff System Technology Corp.
Product code: Code LEJ
Device class: Class 2
Regulation: 21 CFR 878.4635
Advisory panel: General, Plastic Surgery
Date received: 1987-09-04
Decision date: 1987-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlstadt, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LEJ

view all

K221523 — Tanning Lamp2023-02-15
K220500 — 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 Ergoline2022-07-01
K191881 — KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun2019-10-28
K190173 — Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound2019-05-10
K183539 — Ergoline Sunrise 7200 Hybrid Technology2019-04-08

More clearances from Wolff System Technology Corp.

view all

K151841 — Ultraviolet Sunlamps2015-10-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.