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FDA 510(k)

CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER

K-Number: K950684 · 1995-08-16

ApplicantCynosure, Inc.
Decision Date1995-08-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, Inc.. It received FDA 510(k) clearance on 1995-08-16 under 510(k) number K950684. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER?

CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER is a medical device that received FDA 510(k) clearance on 1995-08-16. The listed applicant is Cynosure, Inc.. The 510(k) number is K950684.

When did CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER receive FDA 510(k) clearance?

CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER received FDA 510(k) clearance on 1995-08-16, under 510(k) number K950684.

Who is the listed applicant for CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER?

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

What is the FDA product code for CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER?

The FDA product code for CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

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