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Device Explorer · FDA GUDID · GMDN 61216

Cosmetic micro-needling electronic handpiece, professional

A hand-held, electrically-powered device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as par

US‑registered devices54in commercial distribution
Companies18labelers on GUDID
Single‑use9%of device records
Sterile4%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Cytrellis Biosystems, Inc.1528%
Mt.Derm Gmbh1019%
Bellus Medical, Llc713%
Induction Therapies, Llc47%
Endymed Medical Ltd36%
Guangzhou Ekai Electronic Technology Co.,Ltd.24%
Dermaroller Gmbh24%
Bg Makeovers Advanced Skin Care12%

Top labelers

CompanyDevicesShare
Cytrellis Biosystems, Inc.1528%
Mt.Derm Gmbh1019%
Bellus Medical, Llc713%
Induction Therapies, Llc47%
Endymed Medical Ltd36%
Guangzhou Ekai Electronic Technology Co.,Ltd.24%
Dermaroller Gmbh24%
Bg Makeovers Advanced Skin Care12%
T Aesthetics Llc12%
Eclipse12%
Zizion Group Inc.12%
Hydrafacial Llc12%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

endyMed PRO MAX, Intensif MAX HandpieceEndyMed Pure Intensif HandpieceEndyMed PRO Intensif HandpieceDr.PenXCELLARISPRO TWIST HandpieceXCELLARISPRO TWIST microneedling devicePlatinum Pro Microneedling PenSkinPen Precision Charging BaseSkinPen Precision Microneedling SystemSkinPen Precision HandpieceLuxPenEclipse MicroPen EVONanoPenSkinPen Precision EliteSP MicroPen EVOCollagen P.I.N.

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
QAIPowered Microneedle Device53
GEIElectrosurgical, Cutting & Coagulation & Accessories3
OUHSkin Resurfacing Rf Applicator2
QAIPowered microneedle device1

GMDN & GCC registration

  • GMDN code 61216 · non‑implantable
  • Single‑use 9% · sterile 4% · Rx‑only 91% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many cosmetic micro-needling electronic handpiece, professional products are registered in the US?

54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cosmetic micro-needling electronic handpiece, professional", from 18 companies. The largest labeler is Cytrellis Biosystems, Inc. with 28% of records.

Which FDA product codes apply?

QAI (Powered Microneedle Device), GEI (Electrosurgical, Cutting & Coagulation & Accessories), OUH (Skin Resurfacing Rf Applicator), QAI (Powered microneedle device)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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