Cleared Traditional

K132796 - SUNTOUCH EYE SPEAR

K132796 is an FDA 510(k) clearance for SUNTOUCH EYE SPEAR, manufactured by Huizhou Foryou Medical Devices Co., Ltd.. The device is a Class 2 Ophthalmic device with product code HOZ cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K132796 · Huizhou Foryou Medical Devices Co., Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
54d
Days
Class 2
Risk

K132796 is an FDA 510(k) clearance for the SUNTOUCH EYE SPEAR. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 30, 2013 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4790 - 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.

FDA 510(k) Submission Details - K132796

510(k) Number K132796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2013
Decision Date October 30, 2013
Days to Decision 54 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
56d faster than avg
Panel avg: 110d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HOZ Device Classification - Class 2, Special Controls

Product Code HOZ Sponge, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4790
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 - HOZ Sponge, Ophthalmic

All 46
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K132796.
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K012196 · Ultracell Medical Technologies, Inc. · Aug 2001
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K011191 · Medtronic Xomed, Inc. · Jun 2001
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K003842 · Prescott'S, Inc. · Apr 2001
K132796 · SUNTOUCH EYE SPEAR
Download PDF FDA Summary Huizhou Foryou Medica…