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FDA 510(k)

ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY

K-Number: K853875 · 1986-01-09

ApplicantEndo Lase, Inc.
Decision Date1986-01-09
Product CodeEWG
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Endo Lase, Inc.. It received FDA 510(k) clearance on 1986-01-09 under 510(k) number K853875. 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 ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY?

ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY is a medical device that received FDA 510(k) clearance on 1986-01-09. The listed applicant is Endo Lase, Inc.. The 510(k) number is K853875.

When did ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY receive FDA 510(k) clearance?

ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY received FDA 510(k) clearance on 1986-01-09, under 510(k) number K853875.

Who is the listed applicant for ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY?

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

What is the FDA product code for ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY?

The FDA product code for ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY is EWG.

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Other records listing Endo Lase, 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.

K853900ENDO-LASE CD40 FOR NEUROSURGERYK853878ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERYK855093MEDILAS 2 ND:YAG LASER SURGERY SYSTEMK853903ENDO-LASE CD40 CO2 FOR GYNECOLOGYK853876ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGYK853901ENDO-LASE CD 40 FOR DERMATOLOGY

View all 24 devices →

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 OYK880428ILLUMINA 25 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880427ILLUMINA 40 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880429ILLUMINA 55 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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