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FDA 510(k)

BIOPHOTAS LIFELIGHT

K-Number: K122237 · 2013-01-03

ApplicantBiophotas, Inc.
Decision Date2013-01-03
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIOPHOTAS LIFELIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Biophotas, Inc.. It received FDA 510(k) clearance on 2013-01-03 under 510(k) number K122237. 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 BIOPHOTAS LIFELIGHT?

BIOPHOTAS LIFELIGHT is a medical device that received FDA 510(k) clearance on 2013-01-03. The listed applicant is Biophotas, Inc.. The 510(k) number is K122237.

When did BIOPHOTAS LIFELIGHT receive FDA 510(k) clearance?

BIOPHOTAS LIFELIGHT received FDA 510(k) clearance on 2013-01-03, under 510(k) number K122237.

Who is the listed applicant for BIOPHOTAS LIFELIGHT?

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

What is the FDA product code for BIOPHOTAS LIFELIGHT?

The FDA product code for BIOPHOTAS LIFELIGHT is ILY.

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Other records listing Biophotas, 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.

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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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