Decision Date2023-02-15
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Tanning Lamp is the device name listed in this FDA 510(k) record. The listed applicant is Unilam Co., Ltd.. It received FDA 510(k) clearance on 2023-02-15 under 510(k) number K221523. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tanning Lamp?
Tanning Lamp is a medical device that received FDA 510(k) clearance on 2023-02-15. The listed applicant is Unilam Co., Ltd.. The 510(k) number is K221523.
When did Tanning Lamp receive FDA 510(k) clearance?
Tanning Lamp received FDA 510(k) clearance on 2023-02-15, under 510(k) number K221523.
Who is the listed applicant for Tanning Lamp?
The FDA 510(k) record lists Unilam Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tanning Lamp?
The FDA product code for Tanning Lamp is LEJ.
Related Devices (Code: LEJ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K220500Ergoline 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 ErgolineJk-Holding GmbHK191881KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSunKbl GmbHK190173Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / SoundJk-Holding GmbHK183539Ergoline Sunrise 7200 Hybrid TechnologyJk-Holding GmbHK180555Ergoline Prestige 1600 Hybrid PerformanceJk Holding GmbHK181455ProSun sunlamp products, Luxura sunlamp productsProsun International, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.