510(k) Report

De Novo · Granted

Granted

SkinPen Precision System

DEN160029De NovoGranted Mar 1, 2018604-day reviewClass II21 CFR 878.4430

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bellus Medical, LLC · QAI Powered Microneedle Device

Granted on Mar 1, 2018 as a new device type through De Novo after a 604-day review. 25 later devices descend from it.

Decided
Mar 1, 2018
Review
604 days
Class
Class II
Product code
QAI
Recalls
None

25 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2022: 4 descendants cleared2020: 2 descendants cleared2021: 4 descendants cleared2019: 1 descendant cleared2025: 6 descendants cleared2018: 1 descendant cleared2023: 2 descendants cleared2026: 2 descendants cleared2024: 3 descendants cleared201620182020202220242026
  1. This deviceDEN160029 SkinPen Precision SystemBellus Medical, LLC · 2018
  2. Descendant · cites it directly · 13 of its ownK180778 Exceed Microneedling DeviceMt. Derm GmbH · 2018
  3. Descendant · 2 generations on · 7 of its ownK202243 SkinPen Precision SystemCrown Aesthetics · 2021
  4. Descendant · 3 generations on · 5 of its ownK220506 SkinPen Precision SystemCrown Aesthetics · 2022
  5. Descendant · cites it directly · 3 of its ownK230420 Dr. pen Microneedling SystemGuangzhou Ekai Electronic Technology Co., Ltd. · 2023
  6. Descendant · 4 generations on · 3 of its ownK222199 Collagen P.I.N. (Percutaneous Induction Needling)Induction Therapies, LLC · 2022

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2018: 12019: 12020: 22021: 42022: 42023: 22024: 32025: 62026: 2
2018high 6 (2025) · low 1 (2018)2026

Most influential descendants

Showing 5 of 25 · See all
  • K180778Exceed Microneedling DeviceMt. Derm GmbH · 2018 · cites it directly13descendants
  • K202243SkinPen Precision SystemCrown Aesthetics · 2021 · 2 generations on7descendants
  • K220506SkinPen Precision SystemCrown Aesthetics · 2022 · 3 generations on5descendants
  • K230420Dr. pen Microneedling SystemGuangzhou Ekai Electronic Technology Co., Ltd. · 2023 · cites it directly3descendants
  • K222199Collagen P.I.N. (Percutaneous Induction Needling)Induction Therapies, LLC · 2022 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)DEN160029SkinPen Precision SystemBellus Medical, LLC2018—
+1K180778Exceed Microneedling DeviceMt. Derm GmbH2018—
+2K202243SkinPen Precision SystemCrown Aesthetics2021—
+3K220506SkinPen Precision SystemCrown Aesthetics2022—
+1K230420Dr. pen Microneedling SystemGuangzhou Ekai Electronic Technology Co., Ltd.2023—
+4K222199Collagen P.I.N. (Percutaneous Induction Needling)Induction Therapies, LLC2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201910
202020
202140
202240
202320
202430
202560
202620
FIG. 1 — Lineage of DEN160029, 2018–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QAI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QAI device

  1. #1 K230420 Dr. pen Microneedling Systemscore 14.8 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it? (25)

See all 25

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K180778Exceed Microneedling DeviceMt. Derm GmbH201813
K230420Dr. pen Microneedling SystemGuangzhou Ekai Electronic Technology Co., Ltd.20233
K200044SkinStylus SteriLock MicroSystemEsthetic Education, LLC20202
K182407Exceed Microneedling deviceMt. Derm GmbH20192
K243143E-Pen (E-Pen)Bomtech Electronics Co., Ltd.20250
K241790XCELLARISPRO TWIST microneedling deviceDermaroller GmbH20250
K221070DP4 Microneedling deviceEquipmed USA, LLC20220
K203144MicroPen EVOEclipse Medcorp, LLC20210
K192138Rejuvapen NXTRefine USA, LLC20200

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K180778 (Mt. Derm GmbH, 2018) has gone furthest, with 13 descendants of its own.

How does its category compare?

All QAI devices

QAI Powered Microneedle Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · QAI

6in 2025

2018: 22019: 12020: 22021: 42022: 42023: 22024: 32025: 62026 (partial year): 2
2007high 6 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QAI

160in 2025

2021: 226 days median2022: 172 days median2024: 104 days median2025: 160 days median
2007high 226 (2021) · low 104 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QAI

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QAI

11in 2025

2020: 12021: 22022: 62023: 292024: 52025: 11
2007high 29 (2023) · low 0 (2007)2025

MAUDE reports naming product code QAI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20182—00
20191—10
20202—01
2021422602
2022417206
20232—029
2024310405
20256160011
20262—0—

What is it indicated for?

SkinPen® Precision System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older.

Indications for use as stated in the FDA summary.

Recent decisions in QAI

The QAI category page

  • K252591Automatic Micro Needle System (CODE-X)Woorhi Mechatronics Co., Ltd. · 2026
  • K253002SkinStylus SteriLock MicroSystem (MP1209SL)Esthetic Medical, Inc. · 2026
  • K252752ellacor System with Micro-Coring TechnologyCytrellis Biosystems, Inc. · 2025
  • K253153SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC · 2025
  • K243800PRO Pen Microneedling System (6883)Dermalogica, LLC · 2025

https://510kreport.com/device/DEN160029 · printed Nov 6, 2026

Cite this page

510(k) Report. “DEN160029: SkinPen Precision System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN160029

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026