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FDA 510(k)

MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)

K-Number: K862150 · 1986-09-04

ApplicantDirected Energy, Inc.
Decision Date1986-09-04
Product CodeEWG
Advisory CommitteeEN
DecisionSubstantially Equivalent for Some Indications

Device Summary

MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) is the device name listed in this FDA 510(k) record. The listed applicant is Directed Energy, Inc.. It received FDA 510(k) clearance on 1986-09-04 under 510(k) number K862150. The device is classified under product code EWG. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)?

MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) is a medical device that received FDA 510(k) clearance on 1986-09-04. The listed applicant is Directed Energy, Inc.. The 510(k) number is K862150.

When did MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) receive FDA 510(k) clearance?

MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) received FDA 510(k) clearance on 1986-09-04, under 510(k) number K862150.

Who is the listed applicant for MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)?

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

What is the FDA product code for MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)?

The FDA product code for MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) is EWG.

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Other records listing Directed Energy, Inc. as applicant

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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 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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