Cleared Traditional

K243600 - 3nethra neo HD FA

Also marketed or referenced as:
3nethra neo HD

K243600 is an FDA 510(k) clearance for 3nethra neo HD FA, manufactured by Forus Health Pvt.Ltd. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K243600 · Forus Health Pvt.Ltd · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
266d
Days
Class 2
Risk

K243600 is an FDA 510(k) clearance for the 3nethra neo HD FA. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Forus Health Pvt.Ltd (Bengaluru, IN). The FDA issued a Cleared decision on August 14, 2025 after a review of 266 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - 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 Forus Health Pvt.Ltd devices

FDA 510(k) Submission Details - K243600

510(k) Number K243600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2024
Decision Date August 14, 2025
Days to Decision 266 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
156d slower than avg
Panel avg: 110d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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 - HKI Camera, Ophthalmic, Ac-powered

All 59
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