Cleared Traditional

SPEMBLY 140 CRYOSYSTEM PROBES & TIPS (K823835) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K823835 · Keller Instruments, Inc. · Ophthalmic device
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Jan 1983
Decision
27d
Days
Class 2
Risk

K823835 is an FDA 510(k) clearance for the SPEMBLY 140 CRYOSYSTEM PROBES & TIPS. Classified as Unit, Cryotherapy, Ophthalmic (product code HQA), Class II - Special Controls.

Submitted by Keller Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on January 17, 1983 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4170 - 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 Keller Instruments, Inc. devices

Submission Details

510(k) Number K823835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1982
Decision Date January 17, 1983
Days to Decision 27 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 110d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQA Unit, Cryotherapy, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4170
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.