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FDA 510(k)

MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY

K-Number: K873790 · 1988-01-22

ApplicantCooper Lasersonics, Inc.
Decision Date1988-01-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY 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 1988-01-22 under 510(k) number K873790. 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 MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY?

MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY is a medical device that received FDA 510(k) clearance on 1988-01-22. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K873790.

When did MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY receive FDA 510(k) clearance?

MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY received FDA 510(k) clearance on 1988-01-22, under 510(k) number K873790.

Who is the listed applicant for MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY?

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 MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY?

The FDA product code for MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY is GEX. This falls under the Gastroenterology category.

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Other records listing Cooper Lasersonics, 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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