Cleared Special

K240456 - Bosley Booster 128 Laser Cap (FDA 510(k) Clearance)

Also includes:
Bosley Booster 162 Laser Cap Bosley Booster 288 Laser Cap

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240456 · Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
97d
Days
Class 2
Risk

K240456 is an FDA 510(k) clearance for the Bosley Booster 128 Laser Cap. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC (Miami, US). The FDA issued a Cleared decision on May 22, 2024 after a review of 97 days - within the typical 510(k) review window.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC devices

Submission Details

510(k) Number K240456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2024
Decision Date May 22, 2024
Days to Decision 97 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 114d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

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 106
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