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FDA 510(k)

LUMINA 1600, 3300 AND 6600 SYSTEMS

K-Number: K052814 · 2005-11-30

ApplicantUsa Laser Biotech, Inc.
Decision Date2005-11-30
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LUMINA 1600, 3300 AND 6600 SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Usa Laser Biotech, Inc.. It received FDA 510(k) clearance on 2005-11-30 under 510(k) number K052814. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMINA 1600, 3300 AND 6600 SYSTEMS?

LUMINA 1600, 3300 AND 6600 SYSTEMS is a medical device that received FDA 510(k) clearance on 2005-11-30. The listed applicant is Usa Laser Biotech, Inc.. The 510(k) number is K052814.

When did LUMINA 1600, 3300 AND 6600 SYSTEMS receive FDA 510(k) clearance?

LUMINA 1600, 3300 AND 6600 SYSTEMS received FDA 510(k) clearance on 2005-11-30, under 510(k) number K052814.

Who is the listed applicant for LUMINA 1600, 3300 AND 6600 SYSTEMS?

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

What is the FDA product code for LUMINA 1600, 3300 AND 6600 SYSTEMS?

The FDA product code for LUMINA 1600, 3300 AND 6600 SYSTEMS is ILY.

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Other records listing Usa Laser Biotech, Inc. as applicant

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Related Devices (Code: ILY)

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.

K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)Wuhan PHOMED Technology Company , Ltd.K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)Gigaalaser Company , Ltd.K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc.K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V.K221189OLIZ LTB-1000ALtbio Co., Ltd.K213524CytonPro-5000Cytonsys, Inc.

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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