510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162317Substantially Equivalent

Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens

St. Shine Optical Co., Ltd., New Taipei City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162317 is the FDA 510(k) clearance record for Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens, a class II device, cleared for St. shine Optical Co., Ltd. on under FDA product code LPL (Lenses, Soft Contact, Daily Wear). FDA records list 11 510(k) clearances for St. shine Optical Co., Ltd., from to . As of , FDA records show no recalls naming K162317.

Clearance record

Decision date
Received
(63 days to decision)
Product code
LPL Lenses, Soft Contact, Daily Wear
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
St. shine Optical Co., Ltd. 4,5f # 276-2, Sec. 1, Ta Tung Rd.,Hsi Chih Dist., New Taipei City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LPL

Trailing 12 months
9 clearances under product code LPL in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code LPL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20262
April 20261
May 20263
June 20260
July 20260
August 20260
September 20261
October 20260