Cleared Traditional

K243445 - Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K243445 · Bios S.R.L. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2024
Decision
54d
Days
Class 2
Risk

K243445 is an FDA 510(k) clearance for the Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG). 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 Bios S.R.L. (Vimodrone, IT). The FDA issued a Cleared decision on December 30, 2024 after a review of 54 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bios S.R.L. devices

Submission Details

510(k) Number K243445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2024
Decision Date December 30, 2024
Days to Decision 54 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 114d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04152707 Unknown Interventional Industry-sponsored

Clinical Evaluation of Splendor X for Hair Removal

44
Patients (est.)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Hair Remval
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Thomas Rohrer, Dr.
Sponsor Lumenis Be Ltd. (industry)
Started 2020-01-08 → Primary completion 2023-03-01 → Completed 2023-04-01
Primary outcome
Hair reduction
View full study on ClinicalTrials.gov

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All 2855
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