Cleared Traditional

F65 Laser System (K222790) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222790 · Lumenis Be, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
272d
Days
Class 2
Risk

K222790 is an FDA 510(k) clearance for the F65 Laser System. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Lumenis Be, Ltd. (Yokneam, IL). The FDA issued a Cleared decision on June 14, 2023 after a review of 272 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 890.5500 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Lumenis Be, Ltd. devices

Submission Details

510(k) Number K222790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2022
Decision Date June 14, 2023
Days to Decision 272 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 115d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAP Laser, Comb, Hair
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
Definition Promote Hair Growth In Males With Androgenic Alopecia And Norwood Hamilton Classification Of Iia To V
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OAP Laser, Comb, Hair

All 71
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K222790.
Laser Cap, Model: Hat-01
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Nooance Led And Laser Helmet
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Neuhat Hair Growth System
K231153 · Nature, Inc.redible, Inc. · Jun 2023
Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002
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Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
K223862 · Wontech Co., Ltd. · Apr 2023
Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
K230597 · Light Tree Ventures Europe B.V. · Apr 2023