Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003889343

FEI Number

3003889343

Entity Name

POWERMEDIC APS

City/State/Country

HOLBAEK Sjalland, DK

Establishment Address

8 Gasvaerksvej, HOLBAEK Sjalland 4300, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PowerMedic Worldwide SL (Owner Number: 10094726)

Owner / Operator Contact Address

UR. Lorcrimar III, 01 Pta. C Esc. 6, Nueva Andalucia, Marbella, ES-MA 29660, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K070516

PMA Number

N/A

All Registered Proprietary Names

GigaLaser PowerLaser

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	2025-12-18
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-12-18

Official Correspondent

Arne Grinsted

US Agent Details

Maja Grinsted Hillegass Business: PowerMedic US Inc Email: mh@powermedic.com Phone: (608) 6321033

Related Public Records

Same Entity

PowerMedic Worldwide SL

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003889343. Last updated year: 2026. Please use registration number 3003889343 when referencing this establishment in official correspondence.