FDA 510(k)

ECHO Photocoagulator

K-Number: K222157 · 2022-10-11

Decision Date2022-10-11

Product CodeHQF

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

ECHO Photocoagulator is the device name listed in this FDA 510(k) record. The listed applicant is Norlase. It received FDA 510(k) clearance on 2022-10-11 under 510(k) number K222157. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHO Photocoagulator?

ECHO Photocoagulator is a medical device that received FDA 510(k) clearance on 2022-10-11. The listed applicant is Norlase. The 510(k) number is K222157.

When did ECHO Photocoagulator receive FDA 510(k) clearance?

ECHO Photocoagulator received FDA 510(k) clearance on 2022-10-11, under 510(k) number K222157.

Who is the listed applicant for ECHO Photocoagulator?

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

What is the FDA product code for ECHO Photocoagulator?

The FDA product code for ECHO Photocoagulator is HQF.

Related Devices (Code: HQF)

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.

K252979Voyager DSLT (430840610)Belkin Vision, Ltd.K251507INTEGRE LIOQuantel Medical K251772Navilas Laser System 577sl (156691)Od-Os GmbH K243014EyeQ nanoECPEyeq, Inc.K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.K242397LYNX PhotocoagulatorNorlase Aps

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.