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FDA 510(k)

MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE

K-Number: K963340 · 1997-05-12

ApplicantContinuum Biomedical, Inc.
Decision Date1997-05-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Continuum Biomedical, Inc.. It received FDA 510(k) clearance on 1997-05-12 under 510(k) number K963340. 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 MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE?

MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE is a medical device that received FDA 510(k) clearance on 1997-05-12. The listed applicant is Continuum Biomedical, Inc.. The 510(k) number is K963340.

When did MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE receive FDA 510(k) clearance?

MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE received FDA 510(k) clearance on 1997-05-12, under 510(k) number K963340.

Who is the listed applicant for MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE?

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

What is the FDA product code for MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE?

The FDA product code for MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE is GEX. This falls under the Gastroenterology category.

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Other records listing Continuum Biomedical, Inc. as applicant

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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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