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FDA 510(k)

SUNTANNING DEVICE (SEPAR. FROM K812225)

K-Number: K812521 · 1981-10-02

ApplicantKlafs Sunlight Corp.
Decision Date1981-10-02
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUNTANNING DEVICE (SEPAR. FROM K812225) is the device name listed in this FDA 510(k) record. The listed applicant is Klafs Sunlight Corp.. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812521. 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 SUNTANNING DEVICE (SEPAR. FROM K812225)?

SUNTANNING DEVICE (SEPAR. FROM K812225) is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Klafs Sunlight Corp.. The 510(k) number is K812521.

When did SUNTANNING DEVICE (SEPAR. FROM K812225) receive FDA 510(k) clearance?

SUNTANNING DEVICE (SEPAR. FROM K812225) received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812521.

Who is the listed applicant for SUNTANNING DEVICE (SEPAR. FROM K812225)?

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

What is the FDA product code for SUNTANNING DEVICE (SEPAR. FROM K812225)?

The FDA product code for SUNTANNING DEVICE (SEPAR. FROM K812225) 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 Klafs Sunlight Corp. 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.

K873430FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-12K812225METEC HELARIUM LOUNGE & SKY UNITS

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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