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FDA 510(k)

FACIAL/UPPER BODY UNIT

K-Number: K851859 · 1985-05-14

ApplicantTannhut
Decision Date1985-05-14
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FACIAL/UPPER BODY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Tannhut. It received FDA 510(k) clearance on 1985-05-14 under 510(k) number K851859. 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 FACIAL/UPPER BODY UNIT?

FACIAL/UPPER BODY UNIT is a medical device that received FDA 510(k) clearance on 1985-05-14. The listed applicant is Tannhut. The 510(k) number is K851859.

When did FACIAL/UPPER BODY UNIT receive FDA 510(k) clearance?

FACIAL/UPPER BODY UNIT received FDA 510(k) clearance on 1985-05-14, under 510(k) number K851859.

Who is the listed applicant for FACIAL/UPPER BODY 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 FACIAL/UPPER BODY UNIT?

The FDA product code for FACIAL/UPPER BODY 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 HUTK851255SUN BEDSK840137SILGMANN SOLARIUM S-TYPE 1218 COMBOK837283UNKNOWNK812579SUNTANNING HOME UNITK802756SEMI-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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