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CytoPen S2 12-Pin Microneedling Tip

by Emage Medical, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860012651047 UDI-DI Date14 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
CytoPen S2
Generic Name
Multi-modality skin surface treatment system
Model / Ref / Catalog
12-Pin Microneedling Tip, C12
Primary DI / UDI-DI
00860012651047
510(k) Number
FDA Product Code
QAI
GMDN Term
Multi-modality skin surface treatment system
Device Class
Class II
Regulation Number
878.4430
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K241355)

Other devices from Emage Medical, LLC

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No