Cleared Traditional

K833232 - LASER PROTECTIVE EYESHIELD

K833232 is an FDA 510(k) clearance for LASER PROTECTIVE EYESHIELD, manufactured by Stefanovsky & Assoc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K833232 · Stefanovsky & Assoc. · Ophthalmic device
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Dec 1983
Decision
115d
Days
Class 2
Risk

K833232 is an FDA 510(k) clearance for the LASER PROTECTIVE EYESHIELD. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Stefanovsky & Assoc. (Walker, US). The FDA issued a Cleared decision on December 30, 1983 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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.

View all Stefanovsky & Assoc. devices

FDA 510(k) Submission Details - K833232

510(k) Number K833232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1983
Decision Date December 30, 1983
Days to Decision 115 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 110d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQF Device Classification - Class 2, Special Controls

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
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 - HQF Laser, Ophthalmic

All 144
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K833232.
ARGON/KRYPTON ION LASER PHOTOCOAGULA
K834305 · Nidek, Inc. · Mar 1984
OPHTHALMIC ARGON LASER #700A
K832316 · Laser Industries , Ltd. · Jan 1984
LASER PHOTOCOAGULATOR 1520-A & K
K833533 · Britt Corp., Inc. · Jan 1984
BRITT KRYPTON LASERS 150K & 152K
K813492 · Britt Corp., Inc. · Jan 1982
MODEL 900S INTRAOCULAR PROBE
K812219 · Lumenis, Inc. · Nov 1981
LASER, PHOTOCOAGULATION
K782065 · Cavitron Corp. · Dec 1978