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FDA 510(k)

CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15

K-Number: K002296 · 2000-10-02

ApplicantCeram Optec, Inc.
Decision Date2000-10-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 is the device name listed in this FDA 510(k) record. The listed applicant is Ceram Optec, Inc.. It received FDA 510(k) clearance on 2000-10-02 under 510(k) number K002296. 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 CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15?

CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 is a medical device that received FDA 510(k) clearance on 2000-10-02. The listed applicant is Ceram Optec, Inc.. The 510(k) number is K002296.

When did CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 receive FDA 510(k) clearance?

CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 received FDA 510(k) clearance on 2000-10-02, under 510(k) number K002296.

Who is the listed applicant for CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15?

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

What is the FDA product code for CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15?

The FDA product code for CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 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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