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FDA 510(k)

SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS

K-Number: K861533 · 1986-05-08

ApplicantSunfit, Inc.
Decision Date1986-05-08
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS is the device name listed in this FDA 510(k) record. The listed applicant is Sunfit, Inc.. It received FDA 510(k) clearance on 1986-05-08 under 510(k) number K861533. 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 SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS?

SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS is a medical device that received FDA 510(k) clearance on 1986-05-08. The listed applicant is Sunfit, Inc.. The 510(k) number is K861533.

When did SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS receive FDA 510(k) clearance?

SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS received FDA 510(k) clearance on 1986-05-08, under 510(k) number K861533.

Who is the listed applicant for SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS?

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

What is the FDA product code for SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS?

The FDA product code for SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS 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 Sunfit, Inc. 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.

K864485SUNFIT SUNLAMPK801542SUNBED/SUNROOF OR SUNCOUCH/SUNSKY

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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