Cleared Traditional

Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems (K220877) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220877 · Lumenis Be, Inc. · Ophthalmic device
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Jul 2022
Decision
112d
Days
Class 2
Risk

K220877 is an FDA 510(k) clearance for the Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Lumenis Be, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 15, 2022 after a review of 112 days - within the typical 510(k) review window.

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 Lumenis Be, Inc. devices

Submission Details

510(k) Number K220877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2022
Decision Date July 15, 2022
Days to Decision 112 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
2d slower than avg
Panel avg: 110d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - HQF Laser, Ophthalmic

All 29
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K220877.
Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
K223132 · Iridex Corporation · Nov 2022
Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
K222395 · Ellex Medical Pty, Ltd. · Nov 2022
ECHO Photocoagulator
K222157 · Norlase · Oct 2022
Capsulo
K220430 · Quantel Medical · May 2022
Iridex 810 Laser
K213592 · Iridex Corporation · Mar 2022
Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo
K212630 · Ellex Medical Pty, Ltd. · Dec 2021