Cleared Traditional

K232789 - VIO System (V-1000) (FDA 510(k) Clearance)

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

K232789 · Enspectra Health, Inc. · General & Plastic Surgery device
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Dec 2023
Decision
102d
Days
Class 2
Risk

K232789 is an FDA 510(k) clearance for the VIO System (V-1000). Classified as Multi-photon Imaging (product code QZN), Class II - Special Controls.

Submitted by Enspectra Health, Inc. (Mountain View, US). The FDA issued a Cleared decision on December 22, 2023 after a review of 102 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - 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 Enspectra Health, Inc. devices

Submission Details

510(k) Number K232789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2023
Decision Date December 22, 2023
Days to Decision 102 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
12d faster than avg
Panel avg: 114d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QZN Multi-photon Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
Definition To Provide Visible Illumination Of The Surgical Field Or The Patient
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
NCT05619471 Completed Interventional Industry-sponsored

VIO Imaging for Skin Tissue Assessment (VISTA)

VIO Imaging for Skin Tissue Assessment (VISTA) - a Prospective, Multicenter Investigation of the VIO Device in Subjects Undergoing Routine Biopsy

65
Patients (actual)
2
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Skin Condition; Skin Diseases; Skin Lesion; Skin Abnormalities; Skin Cancer
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Michael Wang, MD, FAAD
Sponsor Enspectra Health (industry)
Started 2022-10-20 → Primary completion 2023-08-11
Primary outcome
Comparative Reader Percentage Agreement
Secondary outcome
Inter-Reader Percentage Agreement
View full study on ClinicalTrials.gov