The Radiancy's Mistral® Device is intended to provide phototherapeutic light and heat energy to the body and is generally indicated to treat dermatological conditions. The Mistral is specifically indicated for hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris which includes pustular acne, and mild to moderate psoriasis in patients with Fitzpatrick skin types I-VI.

Device Description

Radiancy's Mistral Device is a Light and Heat Energy (LHE®) based multi-application device intended for the phototherapeautic treatment of: Hair Removal (HR), Skin Photo Rejuvenation (SPR), Acne Clearance (AC) and Psoriasis Care (PC), Mistral consists of a console, footswitch and interchangeable handpieces. It uses the same technology and has the same indications as the previously cleared SkinStation System.

AI/ML Overview

The provided text is a 510(k) summary for the Radiancy Mistral Device. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, study design, sample sizes, and ground truth establishment are not available in the provided document.

Here's a breakdown of the available and unavailable information:

Table of acceptance criteria and the reported device performance:
- Not Available. The document does not describe specific acceptance criteria (e.g., minimum efficacy rates, safety thresholds) or quantitative performance metrics (e.g., specific percentages of hair reduction, lesion clearance, acne improvement) that the device had to meet. The submission is based on substantial equivalence, implying that its performance is expected to be similar to predicate devices, but no explicit performance data or criteria are listed.
Sample size used for the test set and the data provenance:
- Not Available. The document does not describe a specific clinical study with a test set, sample size, or data provenance (country of origin, retrospective/prospective). Substantial equivalence submissions often rely on existing data for predicate devices or bench testing, not necessarily new, separate clinical efficacy studies with independent test sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Available. Since no specific clinical efficacy study is described, there's no mention of experts establishing ground truth for a test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Available. For the same reason as above, no adjudication method is mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a phototherapeutic light and heat energy system for dermatological conditions, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study or AI assistance is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Available. As no specific efficacy study is detailed, the type of ground truth for such a study is not specified.
The sample size for the training set:
- Not Applicable/Not Available. The concept of a "training set" is typically for machine learning or AI models. This document describes a physical device, and while there would have been development and testing, it's not referred to as a "training set" in the context of AI. No performance or developmental data is provided that would involve specific sample sizes akin to a training set for an algorithm.
How the ground truth for the training set was established:
- Not Applicable/Not Available. Again, the concept of "ground truth" for a "training set" does not apply here in the AI context.

Summary of what is available:

The document establishes substantial equivalence of the Radiancy Mistral Device to predicate devices (Radiancy SkinStation System, General Project's MED FLASH II, and McCue's Energist Ultra VPL) based on:

Identical Intended Use and Indications for Use: Hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris, and mild to moderate psoriasis in patients with Fitzpatrick skin types I-VI.
Identical Principles of Operation: It uses Light and Heat Energy (LHE®) technology.
Similar Technological Characteristics: Consists of a console, footswitch, and interchangeable handpieces.

The basis for market clearance (510(k)) is that the differences between the Mistral and its predicate devices "do not raise new issues of safety and effectiveness." This means the FDA accepted that the device's performance would be equivalent to the already cleared predicate devices, without requiring new, specific clinical efficacy data to be presented in this summary document. Performance data for the predicate devices would have been previously reviewed.

Summary

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K072331

510 (k) SUMMARY

Radiancy (Israel) Ltd.'s Radiancy's Mistral® Device

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Manufacturer:

Radiancy (Israel) Ltd. 9 Gav Rave Street Industrial Park Yavne Israel Telephone: +972-8-9438010 +972-8-9438020 Facsimile:

JAN - 7 2008

Contact Person:

Zvi Ladin, PhD. Principal Boston MedTech Advisors, Inc. 990 Washington Street Suite #204 Dedham, MA 02026 Telephone: (781) 407 0900 x104 Facsimile: (781) 407 0901 Email: zladin@bmtadvisors.com

Date Prepared:

August 15, 2007

Name of Device and Name/Address of Sponsor

Trade/Proprietary Name:	Radiancy Mistral® Device
Common Name:	Pulsed Light System and Light Unit Assembly (LUA)
Classification Name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology (21 C.F.R. § 878.4810)
Manufacturing Facility:	Radiancy (Israel) Ltd.9 Gan Rave StreetIndustrial ParkYavne, Israel

Establishment
Registration Number:	9616256
Owner/operator number:	9040071

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K072331
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Predicate Devices

Radiancy SkinStation System (K052442), General Project's MED FLASH II (K051508) and McCue's Energist Ultra VPL (K060234).

Intended Use / Indications for Use

Technological Characteristics

Substantial Equivalence

The Radiancy Mistral Device has the same intended use and indications for use, principles of operation and technological characteristics as the cleared Radiancy SkinStation. When used for hair removal, it has the same intended use, indications for use and is technologically similar to General Project's MED FLASH II and McCue's Ultra VPL devices. The slight differences between Mistral and its predicate devices do not raise new issues of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

JAN - 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Radiancy (Israel) Ltd. % Boston MedTech Advisors, Inc. Zvi Ladin, Ph.D. 990 Washington Street, Suite 204 Dedham, Massachusetts 02026

Re: K072331

Trade/Device Name: Radiancy Mistral Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: November 8, 2007 Received: November 9, 2007

Dear Dr. Ladin:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); good manufacturing practice requirements as set

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Page 2 - Zvi Ladin, Ph.D.

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K092331

Radiancy Mistral Device

Device Name:

Indications For Use:

The Radiancy's Mistral Device is intended to provide phototherapeutic light and heat energy to the body and is generally indicated to treat dermatological conditions. The Mistral is specifically indicated for hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris which includes pustular acne, in patients with Fitzpatrick skin types I - VI, and mild to moderate psoriasis in patients with Fitzpatrick skin types I - VI.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of

K072331 510(k) Number

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.