Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009424883

FEI Number

3009424883

Entity Name

FIREFLY GLOBAL

City/State/Country

Belmont, MA, US

Establishment Address

556 Trapelo Road, Suite 2F, Belmont, MA 02478, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Firefly Global (Owner Number: 10038552)

Owner / Operator Contact Address

556 Trapelo Road, Suite 2F, Belmont, MA 02478, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FIREFLY DE300 DERMATOSCOPE FIREFLY DE350 DERMATOSCOPE FIREFLY DE330T TRICHOSCOPE FIREFLY DE605 GENERAL EXAM CAMERA FIREFLY DE370 DERMATOSCOPE CAMERA ADAPTER ES615 FIREFLY DE608 GENERAL EXAM CAMERA FIREFLY DE334T TRICHOSCOPE FIREFLY DE308 DERMATOSCOPE FIREFLY ES140 FORCEPS FIREFLY DE400 DIGITAL SCOPE FIREFLY DE408 DIGITAL SCOPE FIREFLY ES201 REDFIN ES201 FIREFLY ES204 REDFIN ES204 FIREFLY DE550 OTOSCOPE FIREFLY DE500 OTOSCOPE FIREFLY SPECULA ES100, ES103, ES104, ES105, ES120, ES1040, ES2040 FIREFLY ES160 VIDEO ADAPTER FIREFLY ES150 USB ADAPTER FIREFLY ES170 SPECULA DISPENSER FIREFLY VETERINARY OTOSCOPE DE501 FIREFLY VETERINARY OTOSCOPES DE551, DE571 FIREFLY VETERINARY SPECULA ES101, ES108 FIREFLY VETERINARY OTOSCOPE FORCEPS ES140/ES141 FIREFLY DE570 OTOSCOPE FIREFLY DE508 OTOSCOPE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2013-12-17
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-06-16
HRB	Microscope, Operating, Non-Electric, Ophthalmic	General, Plastic Surgery	Class 1	878.4700	2013-12-17
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2016-02-09
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2013-12-17

Official Correspondent

Kapriel Karagozyan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Firefly Global

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

Similar Registrations

Registration Number	Establishment Name	Location
3024680050	FIREFLY VEIN LIGHT LLC	Chattanooga, TN, US
3015438293	MACQUARIE MEDICAL SYSTEMS PVT. LTD	Leichhardt New South Wales, AU
3012499069	CANFIELD SCIENTIFIC, INC.	Parsippany, NJ, US
3012678246	TYTOCARE LTD.	Netanya Central, IL
1421873	XEMAX SURGICAL PRODUCTS, INC.	NAPA, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009424883. Last updated year: 2026. Please use registration number 3009424883 when referencing this establishment in official correspondence.