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FDA 510(k)

SUNLAMP MODELS 24N, 30R, 30RE, 37RE

K-Number: K860347 · 1986-02-12

ApplicantGti, Inc.
Decision Date1986-02-12
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUNLAMP MODELS 24N, 30R, 30RE, 37RE is the device name listed in this FDA 510(k) record. The listed applicant is Gti, Inc.. It received FDA 510(k) clearance on 1986-02-12 under 510(k) number K860347. 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 SUNLAMP MODELS 24N, 30R, 30RE, 37RE?

SUNLAMP MODELS 24N, 30R, 30RE, 37RE is a medical device that received FDA 510(k) clearance on 1986-02-12. The listed applicant is Gti, Inc.. The 510(k) number is K860347.

When did SUNLAMP MODELS 24N, 30R, 30RE, 37RE receive FDA 510(k) clearance?

SUNLAMP MODELS 24N, 30R, 30RE, 37RE received FDA 510(k) clearance on 1986-02-12, under 510(k) number K860347.

Who is the listed applicant for SUNLAMP MODELS 24N, 30R, 30RE, 37RE?

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

What is the FDA product code for SUNLAMP MODELS 24N, 30R, 30RE, 37RE?

The FDA product code for SUNLAMP MODELS 24N, 30R, 30RE, 37RE 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 Gti, 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.

K913200GTI CLASP COVER

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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