Cleared Traditional

K223700 - BOSS™ (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K223700 · Intelon Optics, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Aug 2024
Decision
613d
Days
Class 2
Risk

K223700 is an FDA 510(k) clearance for the BOSS™. Classified as Device, Analysis, Anterior Segment (product code MXK), Class II - Special Controls.

Submitted by Intelon Optics, Inc. (Woburn, US). The FDA issued a Cleared decision on August 16, 2024 after a review of 613 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Intelon Optics, Inc. devices

Submission Details

510(k) Number K223700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2022
Decision Date August 16, 2024
Days to Decision 613 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
503d slower than avg
Panel avg: 110d · This submission: 613d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MXK Device, Analysis, Anterior Segment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05423041 Completed Interventional Industry-sponsored

A Prospective Clinical Trial Designed to Evaluate the Repeatability and Reproducibility of the Intelon BOSS(tm) System

Prospective Clinical Trial Designed to Evaluate the Repeatability and Reproducibility of the Intelon BOSS(tm) System

34
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Corneal Transplant; Corneal Crosslinking; Healthy Eyes
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Intelon Optics, Inc (industry)
Started 2022-05-14 → Primary completion 2022-09-13
Primary outcome
Analysis of variance in BOSS analysis to determine repeatability and reproducibility
Study completed - no results published. This trial concluded in 2022 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov