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FDA 510(k)

MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE

K-Number: K871579 · 1987-11-16

ApplicantSharplan Lasers, Inc.
Decision Date1987-11-16
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE is the device name listed in this FDA 510(k) record. The listed applicant is Sharplan Lasers, Inc.. It received FDA 510(k) clearance on 1987-11-16 under 510(k) number K871579. 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 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE?

MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE is a medical device that received FDA 510(k) clearance on 1987-11-16. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K871579.

When did MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE receive FDA 510(k) clearance?

MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE received FDA 510(k) clearance on 1987-11-16, under 510(k) number K871579.

Who is the listed applicant for MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE?

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

What is the FDA product code for MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE?

The FDA product code for MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE is HHR.

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Other records listing Sharplan Lasers, 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.

K973354SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)K972099SHARPLAN EPITOUCH RUBY LASER SYSTEMK971874SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)K971648SHARPLAN ERBIUM: YAG LASER (4020)K971743SHARPLAN CO2 SURGICAL LASER SYSTEMK962446SHARPLAN RUBY LASER SYSTEM

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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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