Cleared Traditional

K855105 - SIMMONS SHELL

K855105 is an FDA 510(k) clearance for SIMMONS SHELL, manufactured by Mira, Inc.. The device is a Class 2 Ophthalmic device with product code HQT cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K855105 · Mira, Inc. · Ophthalmic device
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Mar 1986
Decision
98d
Days
Class 2
Risk

K855105 is an FDA 510(k) clearance for the SIMMONS SHELL. Classified as Shell, Scleral (product code HQT), Class II - Special Controls.

Submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on March 31, 1986 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3800 - 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 Mira, Inc. devices

FDA 510(k) Submission Details - K855105

510(k) Number K855105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1985
Decision Date March 31, 1986
Days to Decision 98 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
12d faster than avg
Panel avg: 110d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQT Device Classification - Class 2, Special Controls

Product Code HQT Shell, Scleral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3800
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.