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FDA 510(k) Applications for Medical Device Product Code "QAI"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN160029
BELLUS MEDICAL, LLC.
SkinPen Precision System
03/01/2018
K202243
Crown Aesthetics
SkinPen Precision System
04/02/2021
K220506
Crown Aesthetics
SkinPen Precision System
03/07/2022
K202517
Cytrellis Biosystems, Inc.
Cytrellis Dermal Micro-Coring System
07/09/2021
K212558
Eclipse Medcorp LLC
MicroPen EVO
11/24/2021
K203144
Eclipse MedCorp, LLC
MicroPen EVO
05/25/2021
K221070
Equipmed USA LLC
DP4 Microneedling device
12/20/2022
K200044
Esthetic Education LLC
SkinStylus SteriLock MicroSystem
04/10/2020
K231073
Esthetic Medical Inc.
SkinStylus SteriLock« MicroSystem, Model Number MP1209SL
07/28/2023
K230420
Guangzhou Ekai Electronic Technology Co., Ltd.
Dr. pen Microneedling System
08/11/2023
K222199
Induction Therapies LLC
Collagen P.I.N. (Percutaneous Induction Needling)
10/21/2022
K182407
Mt. Derm GmbH
Exceed Microneedling device
07/19/2019
K180778
MT.DERM GmbH
Exceed Microneedling Device
09/07/2018
K192138
Refine USA LLC
Rejuvapen NXT
04/09/2020
K221011
Venus Concept USA Inc.
AI.ME System
12/20/2022
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