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FDA 510(k)

MONITOR CO2 LASER SURGICAL SYSTEM

K-Number: K840145 · 1984-04-25

ApplicantCooper Lasersonics, Inc.
Decision Date1984-04-25
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MONITOR CO2 LASER SURGICAL SYSTEM 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 1984-04-25 under 510(k) number K840145. 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 MONITOR CO2 LASER SURGICAL SYSTEM?

MONITOR CO2 LASER SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K840145.

When did MONITOR CO2 LASER SURGICAL SYSTEM receive FDA 510(k) clearance?

MONITOR CO2 LASER SURGICAL SYSTEM received FDA 510(k) clearance on 1984-04-25, under 510(k) number K840145.

Who is the listed applicant for MONITOR CO2 LASER SURGICAL SYSTEM?

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 MONITOR CO2 LASER SURGICAL SYSTEM?

The FDA product code for MONITOR CO2 LASER SURGICAL SYSTEM is HQF.

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Other records listing Cooper Lasersonics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K880808ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SUK880807ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SUK880427ILLUMINA 40 CO2 LASER SYSTEMK880428ILLUMINA 25 CO2 LASER SYSTEMK880429ILLUMINA 55 CO2 LASER SYSTEMK880809ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU

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Related Devices (Code: 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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