Cleared Traditional

K251077 - JOULE 1064nm System and Accessories (FDA 510(k) Clearance)

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

K251077 · Sciton, Inc · General & Plastic Surgery device
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Dec 2025
Decision
255d
Days
Class 2
Risk

K251077 is an FDA 510(k) clearance for the JOULE 1064nm System and Accessories. 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 Sciton, Inc (Palo Alto, US). The FDA issued a Cleared decision on December 19, 2025 after a review of 255 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 Sciton, Inc devices

Submission Details

510(k) Number K251077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2025
Decision Date December 19, 2025
Days to Decision 255 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
141d slower than avg
Panel avg: 114d · This submission: 255d
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
NCT04744935 Active not recruiting Interventional

Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma

40
Patients (est.)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Basal Cell Carcinoma; Superficial Basal Cell Carcinoma; Nodular Basal Cell Carcinoma
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Christopher Zachary, MBBS FRCP
Sponsor Christopher Zachary
Started 2021-01-13 → Primary completion 2027-02-17
Primary outcome
Complete histological clearance of BCC lesion
View full study on ClinicalTrials.gov

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 2855
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K251077.
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