510(k) K252979

Device
Voyager DSLT (430840610)
Applicant
Belkin Vision, Ltd.
510(k) number
K252979
Product code
HQF
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-07
Date received
2025-09-17
Regulation
886.4390
Classification name
Laser, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Tamar Mor-Yosef Weizman
Address
A Wholly Owned Subsidiary Of Alcon Laboratories, Inc. 13 Gan Rave Blvd. Yavne IL 8122214 8122214

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code HQF

510(k)DeviceApplicantDecision date
K251507INTEGRE LIOQuantel Medical2026-02-06
K251772Navilas Laser System 577sl (156691)Od-Os GmbH2025-10-29
K243014EyeQ nanoECPEyeq, Inc.2025-06-18
K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.2025-04-03
K242397LYNX PhotocoagulatorNorlase Aps2024-10-25
K233911VISULAS combiCarl Zeiss Meditec, AG2024-09-06
K232417MR Q; MR Q SUPINE; MR Q SLTMeridian AG2024-01-25
K230722Eagle deviceBelkin Vision, Ltd.2023-12-08
K232051VISULAS greenCarl Zeiss Meditec2023-10-24
K230350VISULAS yagCarl Zeiss Meditec, Inc.2023-09-22
K231011Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulseMeridian AG2023-09-12
K230228Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)Iridex Corporation2023-02-23
K220974R:GENLutronic Vision, Inc.2022-12-27
K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex Corporation2022-11-09
K222395Tango Neo, Tango Reflex Neo, Ultra Q Reflex NeoEllex Medical Pty, Ltd.2022-11-02