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5350 - Device Class 2 4. Predicate Device - Manufacturer Jeisys Medical Incorporated IME Co. Ltd. INTRAcel Premium Fractional HR-5000 RF Micro Needle FRM System 510 k number K153727 K881276 5. Electrocoagulation and hemostasis. 7. Substantial Equivalence AGNES is substantially equivalent to the predicate device HR-5000 K881276 by IME Co. 2. 0mm. The predicate devices needle length 0. 5/0. 8/1. 5/2. 0mm in K153727 0. 5 to 2. 0 mm in K12336 and 1....

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