EMAGE MEDICAL, LLC

FDA Device Registration & Listing · Charlotte, NC, US · Registration 3007645866

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007645866
FEI Number
3007645866
Entity Name
EMAGE MEDICAL, LLC
City/State/Country
Charlotte, NC, US
Establishment Address
7515 Robin Crest Rd, Charlotte, NC 28226, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Emage Medical, LLC (Owner Number: 10082979)
Owner / Operator Contact Address
7515 Robin Crest Rd, Charlotte, NC 28226, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CytoPen S2 CytoPen NG CytoPeel V1, CytoPeel V2, CytoPeel V3

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QAI Powered Microneedle Device General, Plastic Surgery Class 2 878.4430 2025-04-25
QAI Powered Microneedle Device General, Plastic Surgery Class 2 878.4430 2024-09-18
GFE Brush, Dermabrasion, Powered General, Plastic Surgery Class 1 878.4820 2023-04-29

Official Correspondent

Lonnie Roy Wallace

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Emage Medical, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007645866. Last updated year: 2026. Please use registration number 3007645866 when referencing this establishment in official correspondence.
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