Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015259874

FEI Number

3015259874

Entity Name

PELLECOME LLC

City/State/Country

Gladstone, NJ, US

Establishment Address

240 Main Street, Bldg A, Suite 1, Gladstone, NJ 07934, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Pellecome LLC (Owner Number: 10059229)

Owner / Operator Contact Address

240 Main Street, Gladstone, NJ 07934, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Re3 Male Scalpel PEL5 Re3 Accessory Needle PEL7 Re3 Advanced Pellet Delivery System for Men & Pellecome Fit PEL2 Re3 Advanced Pellet Delivery System for Men PEL1 Re3 Advanced Pellet Delivery System for Women PEL3 Re3 Procedural Accessory Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2019-05-22
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-12-13

Official Correspondent

Enrique Jacome

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pellecome 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 3015259874. Last updated year: 2026. Please use registration number 3015259874 when referencing this establishment in official correspondence.