Cleared Traditional

K931356 - SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR

K931356 is an FDA 510(k) clearance for SAFE AIR VARI-SPOT HANDPIECE TELESCOPE ..., manufactured by Sorenson Laboratories, Inc.. The device is a Class 2 Ophthalmic device with product code LQJ cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K931356 · Sorenson Laboratories, Inc. · Ophthalmic device
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Sep 1993
Decision
174d
Days
Class 2
Risk

K931356 is an FDA 510(k) clearance for the SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR. Classified as Lens, Surgical, Laser, Accesssory, Ophthalmic Laser (product code LQJ), Class II - Special Controls.

Submitted by Sorenson Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 7, 1993 after a review of 174 days - an extended review cycle.

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 Sorenson Laboratories, Inc. devices

FDA 510(k) Submission Details - K931356

510(k) Number K931356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date September 07, 1993
Days to Decision 174 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 110d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQJ Device Classification - Class 2, Special Controls

Product Code LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
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 - LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser

All 8
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