Largan Medical Co., Ltd. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens510(k)Feb 4, 2025Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Feb 4, 2025
LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)510(k)Jul 26, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jul 26, 2024
Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo510(k)Apr 1, 2021Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Apr 1, 2021