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Cooper Medical Model 770

by Cooper Medical Corp. United States 510(k)

510(k) K833497

Product code LLF

Overview

The Cooper Medical Model 770 is an Argon Laser Surgical System classified as a neurosurgical laser. This device emits coherent light at specific wavelengths to perform precise tissue ablation, coagulation, or vaporisation, primarily used in neurosurgical and gastrointestinal procedures.

This system is supplied as a reusable medical device and is intended for use in controlled surgical environments. It is not classified as MRI-safe or MRI-conditional, and its regulatory status includes FDA 510(k) clearance under Traditional review (K833497). The device is designed for surgical applications and adheres to Class III regulatory classification as per FDA categorisation.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK833497 Date17 Apr 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

510(k) · synced 6 Oct 2026

510(k) Number
FDA Product Code
LLF
Device Class
Class III
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

Other devices from Cooper Medical Corp.

Questions

  • What types of surgical procedures is the Cooper Medical Model 770 Argon Laser Surgical System primarily used for?

    The Cooper Medical Model 770 is designed for neurosurgical and gastrointestinal procedures where precise tissue ablation, coagulation, or vaporisation is required. Its coherent light emission at specific wavelengths allows for controlled surgical interventions in these specialized areas.

  • Is the Cooper Medical Model 770 a single-use or reusable device?

    The Cooper Medical Model 770 is supplied as a reusable medical device, meaning it is intended for repeated use in controlled surgical environments after proper cleaning, maintenance, and sterilization procedures.

  • How was the regulatory clearance for this device obtained, and what does that mean for its use?

    The Cooper Medical Model 770 received FDA clearance through a 510(k) Traditional review process (K833497) and is classified as Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, allowing it to be legally marketed in the U.S. under Class III regulatory classification.

  • Can this device be used in an MRI environment, and if not, why?

    No, the Cooper Medical Model 770 is not classified as MRI-safe or MRI-conditional, meaning it should not be used in an MRI environment. This is explicitly stated in the device’s specifications, as its design and materials may interfere with MRI compatibility.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K833497 24 fields · synced 6 Oct 2026