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FDA 510(k)

METEC HELARIUM LOUNGE & SKY UNITS

K-Number: K812225 · 1982-03-15

ApplicantKlafs Sunlight Corp.
Decision Date1982-03-15
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

METEC HELARIUM LOUNGE & SKY UNITS 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 1982-03-15 under 510(k) number K812225. 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 METEC HELARIUM LOUNGE & SKY UNITS?

METEC HELARIUM LOUNGE & SKY UNITS is a medical device that received FDA 510(k) clearance on 1982-03-15. The listed applicant is Klafs Sunlight Corp.. The 510(k) number is K812225.

When did METEC HELARIUM LOUNGE & SKY UNITS receive FDA 510(k) clearance?

METEC HELARIUM LOUNGE & SKY UNITS received FDA 510(k) clearance on 1982-03-15, under 510(k) number K812225.

Who is the listed applicant for METEC HELARIUM LOUNGE & SKY UNITS?

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 METEC HELARIUM LOUNGE & SKY UNITS?

The FDA product code for METEC HELARIUM LOUNGE & SKY UNITS 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.

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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 8-12K812521SUNTANNING DEVICE (SEPAR. FROM K812225)

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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