Home / 510(k) Clearances / K142398

510(k) K142398

Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow by Ellex Medical Pty, Ltd. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2015
Date Received
August 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

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