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FDA 510(k)

ARGON MICROSURIGAL PROTOCOLS

K-Number: K810740 · 1981-08-21

ApplicantLumenis, Inc.
Decision Date1981-08-21
Product CodeEWG
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ARGON MICROSURIGAL PROTOCOLS is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 1981-08-21 under 510(k) number K810740. The device is classified under product code EWG. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARGON MICROSURIGAL PROTOCOLS?

ARGON MICROSURIGAL PROTOCOLS is a medical device that received FDA 510(k) clearance on 1981-08-21. The listed applicant is Lumenis, Inc.. The 510(k) number is K810740.

When did ARGON MICROSURIGAL PROTOCOLS receive FDA 510(k) clearance?

ARGON MICROSURIGAL PROTOCOLS received FDA 510(k) clearance on 1981-08-21, under 510(k) number K810740.

Who is the listed applicant for ARGON MICROSURIGAL PROTOCOLS?

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

What is the FDA product code for ARGON MICROSURIGAL PROTOCOLS?

The FDA product code for ARGON MICROSURIGAL PROTOCOLS is EWG.

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Other records listing Lumenis, 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.

K211979Lumenis Y&R Laser SystemK130195SCANNING LASERLINKK111213VISION ONE LASER SYSTEMK100228VERSAPULSE MODEL P20 LASER SYSTEMK091962POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200K082809ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM

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Related Devices (Code: EWG)

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.

K924652BENSON CCA100Benson Medical Instruments Co.K870587LASERMATIC SURGILASER MODEL 5050Lasermatic OYK880429ILLUMINA 55 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880428ILLUMINA 25 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880427ILLUMINA 40 CO2 LASER SYSTEMCooper Lasersonics, Inc.K872710MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROATDirected Energy, 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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