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FDA 510(k)

CERALAS D10 810NM LASER, MODEL CERALAS D10-60

K-Number: K001975 · 2000-08-04

ApplicantCeram Optec, Inc.
Decision Date2000-08-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CERALAS D10 810NM LASER, MODEL CERALAS D10-60 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 2000-08-04 under 510(k) number K001975. 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 D10 810NM LASER, MODEL CERALAS D10-60?

CERALAS D10 810NM LASER, MODEL CERALAS D10-60 is a medical device that received FDA 510(k) clearance on 2000-08-04. The listed applicant is Ceram Optec, Inc.. The 510(k) number is K001975.

When did CERALAS D10 810NM LASER, MODEL CERALAS D10-60 receive FDA 510(k) clearance?

CERALAS D10 810NM LASER, MODEL CERALAS D10-60 received FDA 510(k) clearance on 2000-08-04, under 510(k) number K001975.

Who is the listed applicant for CERALAS D10 810NM LASER, MODEL CERALAS D10-60?

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 D10 810NM LASER, MODEL CERALAS D10-60?

The FDA product code for CERALAS D10 810NM LASER, MODEL CERALAS D10-60 is GEX. This falls under the Gastroenterology category.

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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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