Cleared Traditional

Alma Harmony (K243044) - FDA 510(k) Clearance

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

K243044 · Alma Lasers, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
196d
Days
Class 2
Risk

K243044 is an FDA 510(k) clearance for the Alma Harmony. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Alma Lasers, Inc. (Buffalo Grove, US). The FDA issued a Cleared decision on April 11, 2025 after a review of 196 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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 Alma Lasers, Inc. devices

Submission Details

510(k) Number K243044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2024
Decision Date April 11, 2025
Days to Decision 196 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 115d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
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 - GEX Powered Laser Surgical Instrument

All 527
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K243044.
CO2 Laser System (CO2 Laser SST-L23)
K250183 · Zhuozhou Summer Star Technologies Co., Ltd. · Apr 2025
Diode laser system (Night Universe
K250206 · Ivylaser (Beijing) Technology Co.,Ltd · Apr 2025
Stellar M22
K250809 · Lumenis Be, Ltd. · Apr 2025
Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
K250656 · Wuhan Pioon Technology Co., Ltd. · Apr 2025
Medical Diode Laser Systems (THEIA808)
K250018 · Gigaalaser Company , Ltd. · Apr 2025
AdvaTx
K250189 · Advalight Aps · Apr 2025