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FDA 510(k)

UV-A SUNTANNING EQUIPMENT

K-Number: K853911 · 1985-10-21

ApplicantEurotan Intl.
Decision Date1985-10-21
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UV-A SUNTANNING EQUIPMENT is the device name listed in this FDA 510(k) record. The listed applicant is Eurotan Intl.. It received FDA 510(k) clearance on 1985-10-21 under 510(k) number K853911. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UV-A SUNTANNING EQUIPMENT?

UV-A SUNTANNING EQUIPMENT is a medical device that received FDA 510(k) clearance on 1985-10-21. The listed applicant is Eurotan Intl.. The 510(k) number is K853911.

When did UV-A SUNTANNING EQUIPMENT receive FDA 510(k) clearance?

UV-A SUNTANNING EQUIPMENT received FDA 510(k) clearance on 1985-10-21, under 510(k) number K853911.

Who is the listed applicant for UV-A SUNTANNING EQUIPMENT?

The FDA 510(k) record lists Eurotan Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UV-A SUNTANNING EQUIPMENT?

The FDA product code for UV-A SUNTANNING EQUIPMENT is FTC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Eurotan Intl. as applicant

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.

K860489EUROTAN BY AYKK840555WALDMANN SUNTANNING EQUIP-MODELS'SK820827P105

Related Devices (Code: FTC)

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.

K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCK250425Ultraviolet Phototherapy DeviceAPK Technology Co., Ltd.K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)Boston Aesthetics, Inc.K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)Xuzhou Kernel Medical Equipment Co., Ltd.K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)Shanghai Sigma High-Tech Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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