K253352

Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses

510(k) number
K253352
Device name
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses
Applicant
Pegavision Corporation TW
Product code
LPL — Lenses, Soft Contact, Daily Wear
Decision date
2026-05-21
Date received
2025-09-30
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K253352.pdf

Official FDA record: K253352
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.