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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact