Cleared Traditional

K220974 - R:GEN

K220974 is an FDA 510(k) clearance for R:GEN, manufactured by Lutronic Vision, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K220974 · Lutronic Vision, Inc. · Ophthalmic device
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Dec 2022
Decision
267d
Days
Class 2
Risk

K220974 is an FDA 510(k) clearance for the R:GEN. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Lutronic Vision, Inc. (Billerica, US). The FDA issued a Cleared decision on December 27, 2022 after a review of 267 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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 Lutronic Vision, Inc. devices

FDA 510(k) Submission Details - K220974

510(k) Number K220974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2022
Decision Date December 27, 2022
Days to Decision 267 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
157d slower than avg
Panel avg: 110d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQF Device Classification - Class 2, Special Controls

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
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 Consultant

RQM+
Dulciana Chan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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