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FDA 510(k)

COOPER LASER SONICS ND: YAG LASER, MODEL 8008

K-Number: K853117 · 1986-08-12

ApplicantCooper Lasersonics, Inc.
Decision Date1986-08-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOPER LASER SONICS ND: YAG LASER, MODEL 8008 is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Lasersonics, Inc.. It received FDA 510(k) clearance on 1986-08-12 under 510(k) number K853117. 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 COOPER LASER SONICS ND: YAG LASER, MODEL 8008?

COOPER LASER SONICS ND: YAG LASER, MODEL 8008 is a medical device that received FDA 510(k) clearance on 1986-08-12. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K853117.

When did COOPER LASER SONICS ND: YAG LASER, MODEL 8008 receive FDA 510(k) clearance?

COOPER LASER SONICS ND: YAG LASER, MODEL 8008 received FDA 510(k) clearance on 1986-08-12, under 510(k) number K853117.

Who is the listed applicant for COOPER LASER SONICS ND: YAG LASER, MODEL 8008?

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

What is the FDA product code for COOPER LASER SONICS ND: YAG LASER, MODEL 8008?

The FDA product code for COOPER LASER SONICS ND: YAG LASER, MODEL 8008 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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