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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
3-4 Second Avenue Mawson Lakes
Adelaide,  AU
Applicant Contact Rashmi Pillay
Correspondent
O`Connell Regulatory Consultants, Inc.
44 Oak Street
Stoneham,  MA  02180
Correspondent Contact Maureen O`Connell
Regulation Number886.4390
Classification Product Code
HQF  
Date Received08/08/2022
Decision Date 11/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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