Cleared Traditional

K810409 - MODEL C2100-SERIES OPHTHALMIC CRYOPROBE

K810409 is an FDA 510(k) clearance for MODEL C2100-SERIES OPHTHALMIC CRYOPROBE, manufactured by Valleylab, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K810409 · Valleylab, Inc. · General & Plastic Surgery device
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Mar 1981
Decision
30d
Days
Class 2
Risk

K810409 is an FDA 510(k) clearance for the MODEL C2100-SERIES OPHTHALMIC CRYOPROBE. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Valleylab, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 20, 1981 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - the FDA general and plastic surgery 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 Valleylab, Inc. devices

FDA 510(k) Submission Details - K810409

510(k) Number K810409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1981
Decision Date March 20, 1981
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEH Device Classification - Class 2, Special Controls

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 91
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K810409.
HISTOFREEZER
K924114 · Solarcare Technologies Corp,Inc. · Feb 1993
HISTOFREEZER
K911420 · Solarcare Technologies Corp,Inc. · Jun 1991
WALLACH COLD SOAKER
K910491 · Wallach Surgical Devices, Inc. · May 1991
CRYOSURGICAL DEVICE 2000
K781956 · Valleylab, Inc. · Jan 1979
CRYOLYZER ALPHA
K760353 · Pilling Co. · Oct 1976