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FDA 510(k)

CO2 SURGICAL LASER SYSTEM XML-10

K-Number: K841860 · 1984-11-08

ApplicantXanar, Inc.
Decision Date1984-11-08
Product CodeEWG
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CO2 SURGICAL LASER SYSTEM XML-10 is the device name listed in this FDA 510(k) record. The listed applicant is Xanar, Inc.. It received FDA 510(k) clearance on 1984-11-08 under 510(k) number K841860. 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 CO2 SURGICAL LASER SYSTEM XML-10?

CO2 SURGICAL LASER SYSTEM XML-10 is a medical device that received FDA 510(k) clearance on 1984-11-08. The listed applicant is Xanar, Inc.. The 510(k) number is K841860.

When did CO2 SURGICAL LASER SYSTEM XML-10 receive FDA 510(k) clearance?

CO2 SURGICAL LASER SYSTEM XML-10 received FDA 510(k) clearance on 1984-11-08, under 510(k) number K841860.

Who is the listed applicant for CO2 SURGICAL LASER SYSTEM XML-10?

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

What is the FDA product code for CO2 SURGICAL LASER SYSTEM XML-10?

The FDA product code for CO2 SURGICAL LASER SYSTEM XML-10 is EWG.

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Other records listing Xanar, 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.

K861688XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15K852436AMBULASEK860496MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARYK853620MODEL XA-50 - CO2 SURGICAL LASERK850804CO 2 SURGICAL LASER SYSTEM NA-30K850805CO 2 SURGICAL LASER SYSTEM MODEL NA-40

View all 12 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 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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