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FDA 510(k)

MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS

K-Number: K854949 · 1986-02-04

ApplicantCooperVision, Inc.
Decision Date1986-02-04
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS is the device name listed in this FDA 510(k) record. The listed applicant is CooperVision, Inc.. It received FDA 510(k) clearance on 1986-02-04 under 510(k) number K854949. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS?

MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS is a medical device that received FDA 510(k) clearance on 1986-02-04. The listed applicant is CooperVision, Inc.. The 510(k) number is K854949.

When did MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS receive FDA 510(k) clearance?

MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS received FDA 510(k) clearance on 1986-02-04, under 510(k) number K854949.

Who is the listed applicant for MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS?

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

What is the FDA product code for MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS?

The FDA product code for MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS is HQF.

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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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