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FDA 510(k)

CO2 LASER

K-Number: K801197 · 1980-06-30

ApplicantAdvanced Biomedical Instruments
Decision Date1980-06-30
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CO2 LASER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biomedical Instruments. It received FDA 510(k) clearance on 1980-06-30 under 510(k) number K801197. The device is classified under product code HHR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO2 LASER?

CO2 LASER is a medical device that received FDA 510(k) clearance on 1980-06-30. The listed applicant is Advanced Biomedical Instruments. The 510(k) number is K801197.

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

CO2 LASER received FDA 510(k) clearance on 1980-06-30, under 510(k) number K801197.

Who is the listed applicant for CO2 LASER?

The FDA 510(k) record lists Advanced Biomedical Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 LASER?

The FDA product code for CO2 LASER is HHR.

Related Clinical Trials

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Other records listing Advanced Biomedical Instruments 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.

K843156BIOLAS YAG 100 CILAS, ERCELAS YAG 100K842670BIOLAS YAG 100K820519BIOPSER

Related Devices (Code: HHR)

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.

K881507ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIESHgm Medical Laser Systems, Inc.K871875MODEL 5050 SURGILASER FOR OB-GYN USELasermatic, Inc.K875314GL-35 COLPOSCOPIC LASER SYSTEMLaser Engineering, Inc.K874615LASER CANNISTER FILTERMedical Marketing, Inc.K880591LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USELaser Peripherals, LLCK880930MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASECopper Lasersonics, Inc.

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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