Cleared Traditional

K250402 - AVAVA™ Skin Treatment System (FDA 510(k) Clearance)

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

K250402 · Avava, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
61d
Days
Class 2
Risk

K250402 is an FDA 510(k) clearance for the AVAVA™ Skin Treatment System. Classified as Powered Laser Surgical Instrument With Microbeamfractional Output (product code ONG), Class II - Special Controls.

Submitted by Avava, Inc. (Waltham, US). The FDA issued a Cleared decision on April 14, 2025 after a review of 61 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 Avava, Inc. devices

Submission Details

510(k) Number K250402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2025
Decision Date April 14, 2025
Days to Decision 61 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
53d faster than avg
Panel avg: 114d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ONG Powered Laser Surgical Instrument With Microbeamfractional Output
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. The Laser Output Is In Form Of Tiny Beams In Micro Range. Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic To Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue. Indication For Use Can Be General And/or Specific. 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
NCT05597267 Active not recruiting Interventional Industry-sponsored

The MIRIA Acne Scar Study

75
Patients (est.)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Acne Scars - Mixed Atrophic and Hypertrophic
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor AVAVA, Inc. (industry)
Started 2022-11-04 → Primary completion 2025-02-28
Primary outcome
ECCA (échelle d'évaluation clinique des cicatrices d'acné) Grading
Secondary outcome
Blinded Evaluation of Treatment Imaging
View full study on ClinicalTrials.gov

Regulatory Peers - ONG Powered Laser Surgical Instrument With Microbeamfractional Output

All 34
Devices cleared under the same product code (ONG) and FDA review panel - the closest regulatory comparables to K250402.
AVAVA™ Skin Treatment System
K252155 · Avava, Inc. · Oct 2025
eCO2 3D
K244060 · Lutronic Corporation · Jul 2025
Fiber Laser Treatment Systems (HS-232,HS-233)
K251031 · Shanghai Apolo Medical Technology Co., Ltd. · Jul 2025
MOSAIC 3D (Surgical Laser)
K233550 · Lutronic Aesthetic · Jan 2024
Miria Skin Treatment System
K223871 · Avava, Inc. · Jun 2023
SR-1 Skin Treatment System
K221268 · Avava, Inc. · Nov 2022