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FDA 510(k)

MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL

K-Number: K844440 · 1985-05-09

ApplicantCooper Lasersonics, Inc.
Decision Date1985-05-09
Product CodeLKW
DecisionSubstantially Equivalent

Device Summary

MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL 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 1985-05-09 under 510(k) number K844440. The device is classified under product code LKW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL?

MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL is a medical device that received FDA 510(k) clearance on 1985-05-09. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K844440.

When did MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL receive FDA 510(k) clearance?

MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL received FDA 510(k) clearance on 1985-05-09, under 510(k) number K844440.

Who is the listed applicant for MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL?

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 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL?

The FDA product code for MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL is LKW.

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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: LKW)

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.

K875042ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARYSurgilase, Inc.K880172MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.Cooper Lasersonics, Inc.K86416625 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGYWeck Surgical SystemsK853580MEDILAS 2Endo Lase, 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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