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FDA 510(k)

DERMACLEAR UV-B PHOTOTHERAPY SYSTEM

K-Number: K011197 · 2001-12-14

ApplicantLumenis
Decision Date2001-12-14
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMACLEAR UV-B PHOTOTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis. It received FDA 510(k) clearance on 2001-12-14 under 510(k) number K011197. 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 DERMACLEAR UV-B PHOTOTHERAPY SYSTEM?

DERMACLEAR UV-B PHOTOTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-14. The listed applicant is Lumenis. The 510(k) number is K011197.

When did DERMACLEAR UV-B PHOTOTHERAPY SYSTEM receive FDA 510(k) clearance?

DERMACLEAR UV-B PHOTOTHERAPY SYSTEM received FDA 510(k) clearance on 2001-12-14, under 510(k) number K011197.

Who is the listed applicant for DERMACLEAR UV-B PHOTOTHERAPY SYSTEM?

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

What is the FDA product code for DERMACLEAR UV-B PHOTOTHERAPY SYSTEM?

The FDA product code for DERMACLEAR UV-B PHOTOTHERAPY SYSTEM is FTC.

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Other records listing Lumenis 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.

K100415ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEMK030527LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMSK020591BCLEARK011703LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES

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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