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FDA 510(k)

CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR

K-Number: K970243 · 1997-06-03

ApplicantCynosure, Inc.
Decision Date1997-06-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, Inc.. It received FDA 510(k) clearance on 1997-06-03 under 510(k) number K970243. 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 DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR?

CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 1997-06-03. The listed applicant is Cynosure, Inc.. The 510(k) number is K970243.

When did CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR receive FDA 510(k) clearance?

CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR received FDA 510(k) clearance on 1997-06-03, under 510(k) number K970243.

Who is the listed applicant for CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR?

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 DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR?

The FDA product code for CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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