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FDA 510(k)

MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA

K-Number: K863361 · 1986-11-24

ApplicantCooper Lasersonics, Inc.
Decision Date1986-11-24
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA 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 1986-11-24 under 510(k) number K863361. 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 MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA?

MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA is a medical device that received FDA 510(k) clearance on 1986-11-24. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K863361.

When did MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA receive FDA 510(k) clearance?

MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA received FDA 510(k) clearance on 1986-11-24, under 510(k) number K863361.

Who is the listed applicant for MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA?

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 MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA?

The FDA product code for MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA is HHR.

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Other records listing Cooper Lasersonics, Inc. as applicant

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K880427ILLUMINA 40 CO2 LASER SYSTEMK880808ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SUK880428ILLUMINA 25 CO2 LASER SYSTEMK880429ILLUMINA 55 CO2 LASER SYSTEMK880807ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SUK880809ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU

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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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