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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 K212630
Device Name Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo
Applicant
Ellex Medical Pty, Ltd.
3-4 Second Ave. Mawson Lakes
Adelaide,  AU
Applicant Contact Rashmi Pillay
Correspondent
O'Connell Regulatory Consultants, Inc.
44 Oak St.
Stoneham,  MA  02180
Correspondent Contact Maureen O'Connell
Regulation Number886.4390
Classification Product Code
HQF  
Date Received08/19/2021
Decision Date 12/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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