FDA 510(k) K222395, Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo, by Ellex Medical Pty, Ltd.
FDA 510(k) K222395, Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo, by Ellex Medical Pty, Ltd.
Device Classification Name: Laser, Ophthalmic
510(k) Number: K222395
Device Name: Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
Applicant: Ellex Medical Pty, Ltd.
Regulation Number: 886.4390
Classification Product Code: HQF
Date Received: 08/08/2022
Decision Date: 11/02/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
510k Review Panel: Ophthalmic
Total number of pages: 2,605
Fully redacted pages: 2,323
Content pages: 282
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