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FDA 510(k)

SUNTANNING HOME UNIT

K-Number: K812579 · 1981-10-08

ApplicantTannhut
Decision Date1981-10-08
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUNTANNING HOME UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Tannhut. It received FDA 510(k) clearance on 1981-10-08 under 510(k) number K812579. 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 HOME UNIT?

SUNTANNING HOME UNIT is a medical device that received FDA 510(k) clearance on 1981-10-08. The listed applicant is Tannhut. The 510(k) number is K812579.

When did SUNTANNING HOME UNIT receive FDA 510(k) clearance?

SUNTANNING HOME UNIT received FDA 510(k) clearance on 1981-10-08, under 510(k) number K812579.

Who is the listed applicant for SUNTANNING HOME UNIT?

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

What is the FDA product code for SUNTANNING HOME UNIT?

The FDA product code for SUNTANNING HOME UNIT is FTC.

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Other records listing Tannhut 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.

K851858FOLD AWAY HUTK851859FACIAL/UPPER BODY UNITK851255SUN BEDSK840137SILGMANN SOLARIUM S-TYPE 1218 COMBOK837283UNKNOWNK802756SEMI-OVAL MODULAR SUNTANNING BOOTH

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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

View on FDA Database →

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

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