(140 days)
No
The document describes a light and heat energy device for dermatological treatments and does not mention any AI or ML components or capabilities.
Yes
The device is intended to provide phototherapeutic light and heat energy to the body to treat dermatological conditions such as hair removal, vascular and pigmented lesions, acne vulgaris, and psoriasis.
No
Explanation: The device is described as providing light and heat energy to treat dermatological conditions like hair removal, vascular and pigmented lesions, acne, and psoriasis. Its purpose is therapeutic intervention, not diagnosis.
No
The device description explicitly states that the device "consists of a console, footswitch and interchangeable handpieces," indicating it is a hardware device with physical components, not software-only.
Based on the provided information, the Radiancy's Mistral® Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides phototherapeutic light and heat energy to the body to treat dermatological conditions. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description reinforces that it's a multi-application device for phototherapeutic treatment of various skin conditions.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Mistral device does not perform any such analysis of specimens.
Therefore, the Mistral device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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, and mild to moderate psoriasis in patients with Fitzpatrick skin types I-VI.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
phototherapeutic light and heat energy
Anatomical Site
body
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 plastic |
| surgery and in dermatology (21 C.F.R. § 878.4810) | |
| Manufacturing Facility: | Radiancy (Israel) Ltd. |
| 9 Gan Rave Street | |
| Industrial Park | |
| Yavne, 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
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.
Technological Characteristics
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.
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.
2
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
4
Indications for Use
510(k) Number (if known):
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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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K072331 510(k) Number
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