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FDA 510(k)

ACCU-BEAM C02 LASER HANDPIECE

K-Number: K945648 · 1995-02-24

ApplicantTti Medical
Decision Date1995-02-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCU-BEAM C02 LASER HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Tti Medical. It received FDA 510(k) clearance on 1995-02-24 under 510(k) number K945648. 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 ACCU-BEAM C02 LASER HANDPIECE?

ACCU-BEAM C02 LASER HANDPIECE is a medical device that received FDA 510(k) clearance on 1995-02-24. The listed applicant is Tti Medical. The 510(k) number is K945648.

When did ACCU-BEAM C02 LASER HANDPIECE receive FDA 510(k) clearance?

ACCU-BEAM C02 LASER HANDPIECE received FDA 510(k) clearance on 1995-02-24, under 510(k) number K945648.

Who is the listed applicant for ACCU-BEAM C02 LASER HANDPIECE?

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

What is the FDA product code for ACCU-BEAM C02 LASER HANDPIECE?

The FDA product code for ACCU-BEAM C02 LASER HANDPIECE is GEX. This falls under the Gastroenterology category.

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Other records listing Tti Medical as applicant

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Related Devices (Code: GEX)

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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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