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FDA 510(k)

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse

K-Number: K231011 · 2023-09-12

ApplicantMeridian AG
Decision Date2023-09-12
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse is the device name listed in this FDA 510(k) record. The listed applicant is Meridian AG. It received FDA 510(k) clearance on 2023-09-12 under 510(k) number K231011. 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 Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse?

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse is a medical device that received FDA 510(k) clearance on 2023-09-12. The listed applicant is Meridian AG. The 510(k) number is K231011.

When did Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse receive FDA 510(k) clearance?

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse received FDA 510(k) clearance on 2023-09-12, under 510(k) number K231011.

Who is the listed applicant for Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse?

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

What is the FDA product code for Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse?

The FDA product code for Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse is HQF.

Other records listing Meridian AG 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.

K232417MR Q; MR Q SUPINE; MR Q SLTK160677MICRORUPTOR 6

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 MedicalK251772Navilas Laser System 577sl (156691)Od-Os GmbHK243014EyeQ nanoECPEyeq, Inc.K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.K242397LYNX PhotocoagulatorNorlase Aps

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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