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FDA 510(k)

CERALAS D 810 DIODE LASER SYSTEM, MODEL D15

K-Number: K032864 · 2004-03-19

ApplicantBiolitec, Inc.
Decision Date2004-03-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CERALAS D 810 DIODE LASER SYSTEM, MODEL D15 is the device name listed in this FDA 510(k) record. The listed applicant is Biolitec, Inc.. It received FDA 510(k) clearance on 2004-03-19 under 510(k) number K032864. 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 D 810 DIODE LASER SYSTEM, MODEL D15?

CERALAS D 810 DIODE LASER SYSTEM, MODEL D15 is a medical device that received FDA 510(k) clearance on 2004-03-19. The listed applicant is Biolitec, Inc.. The 510(k) number is K032864.

When did CERALAS D 810 DIODE LASER SYSTEM, MODEL D15 receive FDA 510(k) clearance?

CERALAS D 810 DIODE LASER SYSTEM, MODEL D15 received FDA 510(k) clearance on 2004-03-19, under 510(k) number K032864.

Who is the listed applicant for CERALAS D 810 DIODE LASER SYSTEM, MODEL D15?

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

What is the FDA product code for CERALAS D 810 DIODE LASER SYSTEM, MODEL D15?

The FDA product code for CERALAS D 810 DIODE LASER SYSTEM, MODEL D15 is GEX. This falls under the Gastroenterology category.

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Other records listing Biolitec, 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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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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