Data / Medical devices / United States / Emage Medical, LLC

Emage Medical, LLC: FDA-registered device maker in Charlotte, NC, United States, 7 510(k) clearances

Name: Emage Medical, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Emage Medical, LLC is registered with the FDA (registration 3007645866) in Charlotte, NC, United States. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 15, 2025. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3007645866
Address: 7515 Robin Crest Rd, Charlotte, NC, United States, 28226
Owner or operator: Emage Medical, LLC (10082979)
Roles: Complaint file establishment, Repackager or relabeler
First device listed: April 29, 2023
Registered through: 2026
Brand names listed: Cyto-RF, CytoPeel V1, CytoPeel V2, CytoPeel V3, CytoPen NG, CytoPen S2, Preime DermaFacial - AquaB, Preime DermaFacial - Collagen+, Preime DermaFacial - MicroT, Preime DermaFacial - VibroX and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Complaint file establishment	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Complaint file establishment	accessdata.fda.gov
Powered Microneedle Device	QAI	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Stimulator, Transcutaneous Electrical, Aesthetic Purposes	NFO	2	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 15, 2025	K243055	Préime DermaFacial Collagen+	PBX	Substantially Equivalent	EMA Aesthetics , Ltd.	accessdata.fda.gov
April 1, 2025	K243072	Préime DermaFacial (MicroT)	NFO	Substantially Equivalent	EMA Aesthetics , Ltd.	accessdata.fda.gov
October 9, 2024	K241355	SER Pen Carain MicroSystem (MP1209SP)	QAI	Substantially Equivalent	Su-Ko Technologies, LLC	accessdata.fda.gov
June 24, 2024	K233123	SILKRO	GEI	Substantially Equivalent	Hironic Co., Ltd.	accessdata.fda.gov
October 19, 2023	K231749	Radio Frequency System	GEI	Substantially Equivalent	Shenzhenshi Sincoheren S&T Development Co., Ltd.	accessdata.fda.gov
August 11, 2023	K230420	Dr. pen Microneedling System	QAI	Substantially Equivalent	Guangzhou Ekai Electronic Technology Co., Ltd.	accessdata.fda.gov
June 3, 2022	K210084	SILKRO	GEI	Substantially Equivalent	Hironic Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.