HQF · Laser, Ophthalmic

Ophthalmic · 21 CFR 886.4390 · Class 2

Overview

Product CodeHQF
Device NameLaser, Ophthalmic
Regulation21 CFR 886.4390
Device ClassClass 2
Review PanelOphthalmic
3rd-Party ReviewableYes

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Classification Rationale

Class II.

Recent Cleared Devices (20 of 180)

Showing 20 most recent of 180 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K252979Voyager DSLT (430840610)Belkin Vision, Ltd.Apr 7, 2026SESE
K251507INTEGRE LIOQuantel MedicalFeb 6, 2026SESE
K251772Navilas Laser System 577sl (156691)Od-Os GmbHOct 29, 2025SESE
K243014EyeQ nanoECPEyeq, Inc.Jun 18, 2025SESE
K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.Apr 3, 2025SESE
K242397LYNX PhotocoagulatorNorlase ApsOct 25, 2024SESE
K233911VISULAS combiCarl Zeiss Meditec, AGSep 6, 2024SESE
K232417MR Q; MR Q SUPINE; MR Q SLTMeridian AGJan 25, 2024SESE
K230722Eagle deviceBelkin Vision, Ltd.Dec 8, 2023SESE
K232051VISULAS greenCarl Zeiss MeditecOct 24, 2023SESE
K230350VISULAS yagCarl Zeiss Meditec, Inc.Sep 22, 2023SESE
K231011Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulseMeridian AGSep 12, 2023SESE
K230228Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)Iridex CorporationFeb 23, 2023SESE
K220974R:GENLutronic Vision, Inc.Dec 27, 2022SESE
K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex CorporationNov 9, 2022SESE
K222395Tango Neo, Tango Reflex Neo, Ultra Q Reflex NeoEllex Medical Pty, Ltd.Nov 2, 2022SESE
K222157ECHO PhotocoagulatorNorlaseOct 11, 2022SESE
K220877Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser SystemsLumenis Be, Inc.Jul 15, 2022SESE
K220430CapsuloQuantel MedicalMay 12, 2022SESE
K213592Iridex 810 LaserIridex CorporationMar 23, 2022SESE

Top Applicants

Innolitics

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