Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030563436

FEI Number

3030563436

Entity Name

BIOPHOTONICA

City/State/Country

Louisville, CO, US

Establishment Address

913 Main St, Louisville, CO 80027, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Biophotonica (Owner Number: 10092063)

Owner / Operator Contact Address

913 Main Street, Louisville, CO 80027, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ReGen Laser EVOlaser ReGen Pod

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-06-12

Official Correspondent

Ken Teegardin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biophotonica

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 3030563436. Last updated year: 2026. Please use registration number 3030563436 when referencing this establishment in official correspondence.