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FDA 510(k)

ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION

K-Number: K862456 · 1986-08-12

ApplicantCooper Lasersonics, Inc.
Decision Date1986-08-12
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION 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 1986-08-12 under 510(k) number K862456. 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 ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION?

ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION is a medical device that received FDA 510(k) clearance on 1986-08-12. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K862456.

When did ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION receive FDA 510(k) clearance?

ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION received FDA 510(k) clearance on 1986-08-12, under 510(k) number K862456.

Who is the listed applicant for ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION?

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 ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION?

The FDA product code for ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION is HHR.

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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: 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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