Bollé Brands LIGHTSHIFTER XL Black Matte - Frame Only

by Bolle Brands (France) GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00054917312374 UDI-DI	Date22 Sep 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name: Bollé Brands
Generic Name: Prescription spectacles
Model / Reference: LIGHTSHIFTER XL Black Matte - Frame Only

Primary DI / UDI-DI: 00054917312374
FDA Product Code: HQG
GMDN Term: Prescription spectacles

Device Class: Class I
Regulation Number: 886.5844
GUDID distribution status: In Commercial Distribution

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Properties

Single Use
Premarket Exempt
Lot / Batch Number
Serial Number
Manufacturing Date

Other properties (9)

Sterile: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Expiration Date: No