Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on energy delivery (IPL, MP2, RF) without mentioning AI/ML capabilities.

Therapeutic

Yes
The device is indicated for the treatment of various medical conditions such as benign pigmented lesions, benign cutaneous vascular lesions, and acne vulgaris, which are considered therapeutic applications.

Diagnostic

No

The document states that the Venus Versa PRO System is a "multi-application device intended to be used in aesthetic and cosmetic procedures" and lists various treatments it performs (e.g., treatment of pigmented lesions, vascular lesions, hair removal, acne, wrinkle reduction, skin ablation). There is no mention of it being used for the diagnosis of any medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of a console and ten detachable handpieces (applicators) and two disposable tips, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for "aesthetic and cosmetic procedures" and lists various skin treatments (pigmented lesions, vascular lesions, hair removal, acne, wrinkles, skin resurfacing). These are all procedures performed on the patient's body, not tests performed on samples taken from the body.
Device Description: The device description details how the system delivers energy (IPL, MP2, RF) to the patient's skin using applicators. This is consistent with a therapeutic or aesthetic device, not a diagnostic device that analyzes biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to directly treat or alter the skin.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Venus Versa PRO System is a multi-application device intended to be used in aesthetic and cosmetic procedures.

The SR515 and SR580 IPL applicators are indicated for the following:

· Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.

· Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations.

The HR650, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris.

The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for females for the non-invasive treatment of moderate to severe facial wrinkles in Fitzpatrick skin types I-IV.

The Viva MD applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.

Product codes (comma separated list FDA assigned to the subject device)

ONF, GEI, GEX

Device Description

The Venus Versa PRO System is comprised of a console (controller/CPU) and ten detachable handpieces (applicators) and two disposable tips. The system can deliver three types of energies to the patient's skin using the associated ten applicators:

Intense Pulsed Light (IPL)
- 1. SR515
- 1. SR580
- 1. HR650
- 1. HR690
- 1. HR650XL
- 1. HR690XL
- 1. ACDUAL
Magnetic Pulse (MP2)
- 1. Diamondpolar
- 1. Octipolar
Radiofrequency (RF)
- 1. Viva MD (uses 80 and 160 disposable tips)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Summary of Non-Clinical Performance Testing

Electrical Safety: The added changes to the system do not affect the previous test results of IEC 60601-1 Medical electrical equipment, General requirements for Safety.
Electromagnetic Interference (EMC): The added changes to the system do not affect the previous test results for IEC 60601-1-2.
Bench Testing: A bench test was performed to verify that the 80 pin tip delivers the same output power as the predicate device.
Software: Software verification and validation testing has been performed and passed the expected results. In all instances, the device functioned as intended and the results observed were as expected.
Biocompatibility: The 80 pin tip has the same product material as in the predicate device.

Clinical Performance Data
Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K153717

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K201164

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 11, 2023

Venus Concept Inc. % William Mcgrail SVP Technical Operations & Compliance Venus Concept USA Inc. 4001 SW 47th Ave. Suite 206 Davie, Florida 33314

Re: K232192

Trade/Device Name: Venus Versa PRO System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: ONF,GEI, GEX Dated: August 9, 2023 Received: August 10, 2023

Dear William Mcgrail:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

| Mark
Trumbore -S | Digitally signed by
Mark Trumbore -S
Date: 2023.09.11
12:30:57 -04'00' |

---------------------	---------------------------------------------------------------------------------

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

Device Name Venus Versa PRO System

Indications for Use (Describe)