Cleared Traditional

K120057 - ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)

K120057 is an FDA 510(k) clearance for ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGI..., manufactured by Bioptigen, Inc.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K120057 · Bioptigen, Inc. · Ophthalmic device
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May 2012
Decision
123d
Days
Class 2
Risk

K120057 is an FDA 510(k) clearance for the ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS). Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Bioptigen, Inc. (Durham, US). The FDA issued a Cleared decision on May 11, 2012 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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 Bioptigen, Inc. devices

FDA 510(k) Submission Details - K120057

510(k) Number K120057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2012
Decision Date May 11, 2012
Days to Decision 123 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
13d slower than avg
Panel avg: 110d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLI Device Classification - Class 2, Special Controls

Product Code HLI Ophthalmoscope, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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 - HLI Ophthalmoscope, Ac-powered

All 70
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