Cleared Traditional

K021295 - SAVIEW TORIC 55 (METHAFILCON A) SOFT (H...

K021295 is an FDA 510(k) clearance for SAVIEW TORIC 55 (METHAFILCON A) SOFT (H..., manufactured by St. shine Optical Co., Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K021295 · St. shine Optical Co., Ltd. · Ophthalmic device
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Jun 2002
Decision
41d
Days
Class 2
Risk

K021295 is an FDA 510(k) clearance for the SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by St. shine Optical Co., Ltd. (Littleton, US). The FDA issued a Cleared decision on June 4, 2002 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all St. shine Optical Co., Ltd. devices

FDA 510(k) Submission Details - K021295

510(k) Number K021295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2002
Decision Date June 04, 2002
Days to Decision 41 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 110d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPL Device Classification - Class 2, Special Controls

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 165
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K021295.
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