Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015504568

FEI Number

3015504568

Entity Name

I BRAIN ROBOTICS INC

City/State/Country

Melbourne, FL, US

Establishment Address

310 N WICKHAM RD SUITE 129, Melbourne, FL 32935, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

I BRAIN ROBOTICS INC (Owner Number: 10078858)

Owner / Operator Contact Address

3001 Clubview Drive, Orlando, FL 32822, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FUEsion Scalp Pulse HARRTS X-2 HARRTS Mini HARRTS AI Camera HARRTS FUEsion - X HARRTS V-11 HARRTS Precision FUE HARRTS Nano HARRTS FUEsion AI HARRTS FUEsion HARRTS FUEsion AI : AI Assisted Automated Hair Transplant System HARRTS FUEsion X 3 : Robotic Hair Transplant System HARRTS FUEsion X : Robotic Hair Transplant System HARRTS FUEsion Lite 3 Automated Hair Transplant System FUEsion Cam HARRTS FUEsion : Automated Hair Transplant System HARRTS FUEsion AI 3 AI-Assisted Automated Hair Transplant System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2024-01-08
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2020-11-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

I BRAIN ROBOTICS INC

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
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015504568. Last updated year: 2026. Please use registration number 3015504568 when referencing this establishment in official correspondence.