HEAD USA, INC.

FDA Device Registration & Listing · Boulder, CO, US · Registration 3009943650

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009943650
FEI Number
3009943650
Entity Name
HEAD USA, INC.
City/State/Country
Boulder, CO, US
Establishment Address
3125 STERLING CIR STE 101, Boulder, CO 80301, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
HEAD USA INC (Owner Number: 10046072)
Owner / Operator Contact Address
430 South Congress Ave, STE 1A, SUITE 1A, Delray Beach, FL 33445, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

RAPTOR POWER ZONE SHIELD IMPULSE RAVE CONTEX PHOTO black CONTEX PRO 5K red black ICON PRO SIGNATURE 5K PHOTO CONTEX PRO 5K gold petrol CONTEX PRO 5K blue WCR MASTER SIGNATURE 5K blue/black ICON PRO PL PRO ELITE SIGNATURE 5K blue/army grey CONTEX red black HEAD SHIELD silver/black SIGNATURE JOY CONTEX PRO 5K chrome quartz SIGNATURE black/olive SIGNATURE WCR CONTEX PHOTO quartz HEAD SHIELD WCR CONTEX PHOTO WCR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2015-06-26

Official Correspondent

Marco Maestri

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HEAD USA INC
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 3009943650. Last updated year: 2026. Please use registration number 3009943650 when referencing this establishment in official correspondence.
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