Cleared Traditional

K121030 - SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE

K121030 is an FDA 510(k) clearance for SACKS HOLDINGS INC.'S CONTACT LENS STOR..., manufactured by Sacks Holdings, Inc.. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K121030 · Sacks Holdings, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
92d
Days
Class 2
Risk

K121030 is an FDA 510(k) clearance for the SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Sacks Holdings, Inc. (Rancho Santa Fe, US). The FDA issued a Cleared decision on July 6, 2012 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K121030

510(k) Number K121030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2012
Decision Date July 06, 2012
Days to Decision 92 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 110d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRX Device Classification - Class 2, Special Controls

Product Code LRX Case, Contact Lens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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 - LRX Case, Contact Lens

All 67
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K121030.
PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
K130285 · The Lagado Corp. · Apr 2013
POLARIS DIAL-A-DATE CONTACT LENS CASE
K120904 · Reliance Design & Manufacture Corp. · Nov 2012
AC LENS BRANDED CONTACT LENS CASE
K120969 · Arlington Contact Lens Services,Inc. · Jul 2012
EYE CARE CURE CONTACT LENS CASE
K112832 · Eye Care and Cure · Dec 2011
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE
K111856 · Apothecary Products, Inc. · Jul 2011
POLARIS CONTACT LENS CASE
K093377 · Reliance Design & Manufacturing Corp. · Apr 2010
K121030 · SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE
Download PDF FDA Summary Sacks Holdings, Inc.