Not Cleared Direct

DEN200028 - Lumenis Stellar M22 (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200028 · Lumenis, Ltd. · Ophthalmic device
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Feb 2021
Decision
309d
Days
Class 2
Risk

DEN200028 is an FDA 510(k) submission (not cleared) for the Lumenis Stellar M22. Classified as Intense Pulsed Light Device For Managing Dry Eye (product code QIU), Class II - Special Controls.

Submitted by Lumenis, Ltd. (Yokneam, IL). The FDA issued a Not Cleared (DENG) decision on February 23, 2021 after a review of 309 days.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5201 - the FDA ophthalmic device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 309 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Lumenis, Ltd. devices

Submission Details

510(k) Number DEN200028 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 20, 2020
Decision Date February 23, 2021
Days to Decision 309 days
Submission Type Direct
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 110d · This submission: 309d
Pathway characteristics

Device Classification

Product Code QIU Intense Pulsed Light Device For Managing Dry Eye
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5201
Definition An Intense Pulsed Light Device For Managing Dry Eye Is A Prescription Device Intended For Use In The Application Of Intense Pulsed Light Therapy To The Skin. The Device Is Used In Patients With Dry Eye Disease Due To Meibomian Gland Dysfunction, Also Known As Evaporative Dry Eye Or Lipid Deficiency Dry Eye.
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.