Cleared Traditional

K812857 - CHARLES MICRO PROBE

K812857 is an FDA 510(k) clearance for CHARLES MICRO PROBE, manufactured by Mid Laboratories, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K812857 · Mid Laboratories, Inc. · Ophthalmic device
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Feb 1982
Decision
115d
Days
Class 2
Risk

K812857 is an FDA 510(k) clearance for the CHARLES MICRO PROBE. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Mid Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1982 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 886.4150 - 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.

FDA 510(k) Submission Details - K812857

510(k) Number K812857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1981
Decision Date February 05, 1982
Days to Decision 115 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

HQE Device Classification - Class 2, Special Controls

Product Code HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
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 - HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered

All 143
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K812857.
COOPER VISION I/A SYSTEM III MODEL 1500
K822220 · CooperVision, Inc. · Oct 1982
CILCO I/A HANDPIECE
K820933 · Cilco, Inc. · Jun 1982
VERSATOME I
K820008 · Alphamedix, Inc. · Feb 1982
BLOOD POOL & SUBVETINAL FLUID ASPIRATOR
K813274 · Optical Micro Systems, Inc. · Feb 1982
VITRE CON
K820026 · Medical Instrument Development Laboratories, Inc. · Feb 1982
ULTRASONIC FRAGMENTOR
K813389 · Fibra Sonics, Inc. · Feb 1982
K812857 · CHARLES MICRO PROBE
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