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510(k) DEN160029

SkinPen Precision System by Bellus Medical, LLC — Product Code QAI

DEN160029 is an FDA 510(k) premarket notification submitted by Bellus Medical, LLC for the device "SkinPen Precision System". The FDA issued a decision of De Novo Granted on March 1, 2018. The device falls under product code QAI (Powered Microneedle Device), a Class II device regulated under 21 CFR 878.4430.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 1, 2018
Date Received
July 5, 2016
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powered Microneedle Device
Device Class
Class II
Regulation Number
878.4430
Review Panel
SU
Submission Type

A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.

Other clearances for product code QAI

  • K252591 — Automatic Micro Needle System (CODE-X) (May 13, 2026)
  • K253002 — SkinStylus SteriLock MicroSystem (MP1209SL) (February 19, 2026)
  • K252752 — ellacor System with Micro-Coring Technology (October 30, 2025)
  • K253153 — SER Pen Carain MicroSystem (MP1209SP) (October 29, 2025)
  • K243800 — PRO Pen Microneedling System (6883) (August 25, 2025)
  • K243143 — E-PEN (E-PEN) (April 7, 2025)
  • K243472 — 1NEED Pro (March 19, 2025)
  • K241790 — XCELLARISPRO TWIST microneedling device (March 6, 2025)
  • K241355 — SER Pen Carain MicroSystem (MP1209SP) (October 9, 2024)
  • K241400 — SkinPen Precision Elite System (August 29, 2024)

FDA data resources