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FDA 510(k)

BCLEAR

K-Number: K020591 · 2002-05-16

ApplicantLumenis
Decision Date2002-05-16
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BCLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis. It received FDA 510(k) clearance on 2002-05-16 under 510(k) number K020591. 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 BCLEAR?

BCLEAR is a medical device that received FDA 510(k) clearance on 2002-05-16. The listed applicant is Lumenis. The 510(k) number is K020591.

When did BCLEAR receive FDA 510(k) clearance?

BCLEAR received FDA 510(k) clearance on 2002-05-16, under 510(k) number K020591.

Who is the listed applicant for BCLEAR?

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 BCLEAR?

The FDA product code for BCLEAR 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 SYSTEMSK011197DERMACLEAR UV-B PHOTOTHERAPY SYSTEMK011703LUMENIS 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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