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FDA 510(k)

ILLUMINA 55 CO2 LASER SYSTEM

K-Number: K880429 · 1988-04-18

ApplicantCooper Lasersonics, Inc.
Decision Date1988-04-18
Product CodeEWG
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ILLUMINA 55 CO2 LASER SYSTEM 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 1988-04-18 under 510(k) number K880429. 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 ILLUMINA 55 CO2 LASER SYSTEM?

ILLUMINA 55 CO2 LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1988-04-18. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K880429.

When did ILLUMINA 55 CO2 LASER SYSTEM receive FDA 510(k) clearance?

ILLUMINA 55 CO2 LASER SYSTEM received FDA 510(k) clearance on 1988-04-18, under 510(k) number K880429.

Who is the listed applicant for ILLUMINA 55 CO2 LASER SYSTEM?

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 ILLUMINA 55 CO2 LASER SYSTEM?

The FDA product code for ILLUMINA 55 CO2 LASER SYSTEM is EWG.

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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.

K880809ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SUK880427ILLUMINA 40 CO2 LASER SYSTEMK880808ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SUK880807ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SUK880428ILLUMINA 25 CO2 LASER SYSTEMK880171MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL

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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 OYK880427ILLUMINA 40 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880428ILLUMINA 25 CO2 LASER SYSTEMCooper Lasersonics, Inc.K872710MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROATDirected Energy, Inc.K870840MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACHDirected 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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