FDA 510(k)

Vitra 810

K-Number: K201502 · 2020-08-06

Decision Date2020-08-06

Product CodeHQF

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Vitra 810 is the device name listed in this FDA 510(k) record. The listed applicant is Quantel Medical. It received FDA 510(k) clearance on 2020-08-06 under 510(k) number K201502. 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 Vitra 810?

Vitra 810 is a medical device that received FDA 510(k) clearance on 2020-08-06. The listed applicant is Quantel Medical. The 510(k) number is K201502.

When did Vitra 810 receive FDA 510(k) clearance?

Vitra 810 received FDA 510(k) clearance on 2020-08-06, under 510(k) number K201502.

Who is the listed applicant for Vitra 810?

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

What is the FDA product code for Vitra 810?

The FDA product code for Vitra 810 is HQF.

Other records listing Quantel Medical 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.

K251507INTEGRE LIO K232302Pocket III K220430Capsulo K213254Axialis Ophthalmic Ultrasound System K191962Vitra 2 K183414ABSOLU

View all 9 devices →

Related Devices (Code: HQF)

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

View on FDA Database →

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