QAI · Powered Microneedle Device · Chrysalis Intelligence

Device class

Class II

Regulation 878.4430

Total clearances

2020-04-09 → 2026-05-13

Last 12 months

Unique sponsors

Definition

What is Powered Microneedle Device

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

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.4430

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Crown Aesthetics	3	0	2024-08-29
Cytrellis Biosystems, Inc.	2	1	2025-10-30
Esthetic Medical, Inc.	2	1	2026-02-19
Eclipse Medcorp, LLC	2	0	2021-11-24
Su-Ko Technologies, LLC	2	1	2025-10-29
Refine USA, LLC	1	0	2020-04-09
Mt. Derm GmbH	1	0	2024-02-23
Dermalogica, LLC	1	0	2025-08-25
Esthetic Education, LLC	1	0	2020-04-10
Campomats S.R.L.	1	0	2025-03-19
Induction Therapies, LLC	1	0	2022-10-21
Equipmed USA, LLC	1	0	2022-12-20
Dermaroller GmbH	1	0	2025-03-06
Venus Concept USA, Inc.	1	0	2022-12-20
Woorhi Mechatronics Co., Ltd.	1	1	2026-05-13
Guangzhou Ekai Electronic Technology Co., Ltd.	1	0	2023-08-11
Bomtech Electronics Co., Ltd.	1	0	2025-04-07

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
15786	CPT	—	Medium	CPT for non-invasive skin resurfacing procedure using laser or powered device
17999	CPT	—	Medium	CPT for unlisted dermatological procedure with powered microneedle device

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-05-13	K252591	Woorhi Mechatronics Co., Ltd.	Automatic Micro Needle System (CODE-X)
2026-02-19	K253002	Esthetic Medical, Inc.	SkinStylus SteriLock MicroSystem (MP1209SL)
2025-10-30	K252752	Cytrellis Biosystems, Inc.	ellacor System with Micro-Coring Technology
2025-10-29	K253153	Su-Ko Technologies, LLC	SER Pen Carain MicroSystem (MP1209SP)
2025-08-25	K243800	Dermalogica, LLC	PRO Pen Microneedling System (6883)
2025-04-07	K243143	Bomtech Electronics Co., Ltd.	E-PEN (E-PEN)
2025-03-19	K243472	Campomats S.R.L.	1NEED Pro
2025-03-06	K241790	Dermaroller GmbH	XCELLARISPRO TWIST microneedling device
2024-10-09	K241355	Su-Ko Technologies, LLC	SER Pen Carain MicroSystem (MP1209SP)
2024-08-29	K241400	Crown Aesthetics	SkinPen Precision Elite System
2024-02-23	K233709	Mt. Derm GmbH	Exceed Unlimited
2023-08-11	K230420	Guangzhou Ekai Electronic Technology Co., Ltd.	Dr. pen Microneedling System
2023-07-28	K231073	Esthetic Medical, Inc.	SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
2022-12-20	K221070	Equipmed USA, LLC	DP4 Microneedling device
2022-12-20	K221011	Venus Concept USA, Inc.	AI.ME System
2022-10-21	K222199	Induction Therapies, LLC	Collagen P.I.N. (Percutaneous Induction Needling)
2022-03-07	K220506	Crown Aesthetics	SkinPen Precision System
2021-11-24	K212558	Eclipse Medcorp, LLC	MicroPen EVO
2021-07-09	K202517	Cytrellis Biosystems, Inc.	Cytrellis Dermal Micro-Coring System
2021-05-25	K203144	Eclipse Medcorp, LLC	MicroPen EVO
2021-04-02	K202243	Crown Aesthetics	SkinPen Precision System
2020-04-10	K200044	Esthetic Education, LLC	SkinStylus SteriLock MicroSystem
2020-04-09	K192138	Refine USA, LLC	Rejuvapen NXT