(146 days)
Not Found
Not Found
No
The summary describes a phototherapy device with specific light parameters and indications, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes.
The device is intended to treat dermatological conditions, specifically mild to moderate inflammatory acne, by providing phototherapeutic light to the body. This therapeutic function makes it a therapeutic device.
No
The device is intended to treat dermatological conditions, specifically mild and moderate inflammatory acne, not to diagnose them.
No
The device description explicitly details hardware components (ClearTouch LUA, hand piece, flash lamps) and their physical characteristics (wavelength spectrum, pulse duration, spot size), indicating it is a hardware-based medical device.
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 intended to provide phototherapeutic light to the body to treat dermatological conditions, specifically acne. This is a direct treatment applied to the patient's body.
- Device Description: The description details a light-emitting system (flash lamps) used for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a therapeutic device that applies light directly to the body for treatment.
N/A
Intended Use / Indications for Use
The Radiancy Acne System with ClearTouch™ Light Unit Assembly ("Radiancy Acne System") is intended to provide phototherapeutic light to the body. The Radiancy Acne System is generally indicated to treat dermatological conditions. The Radiancy Acne System is specifically indicated to treat mild and moderate inflammatory acne which includes treatment of pustular inflammatory acne in patients with Fitzpatrick skin types I-IV.
Product codes
GEX
Device Description
The ClearTouch LUA is mounted on the hand piece of Radiancy's SpaTouch Photoepilation System (the "SpaTouch"), or on the hair removal / acne hand piece of Radiancy's SkinStation (the "SkinStation"), in order to treat inflammatory acne (the "Radiancy Acne System"). The Radiancy Acne System consists of two green-coated flash lamps. The Radiancy Acne System produces a wavelength spectrum of 430 - 1100 nm with a pulse duration of 35 msec and has a spot size of 22 x 55 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
phototherapeutic light
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)
Clinical data demonstrates that the Radiancy Acne System treats mild and moderate inflammatory acne which include pustular inflammatory acne in patients with Fitzpatrick skin types I-IV.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ClearLight Phototherapy System, Model CT 420
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
DEC 11 2003
510(k) SUMMARY
Radiancy (Israel) Ltd.'s Radiancy Acne System with ClearTouch™ Light Unit Assembly
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Manufacturer:
Radiancy (Israel) Ltd.
9 Gan Ravve Street
Industrial Park
Yavne Israel
Telephone: 011 972-8-9438010
011 972-8-9438020 Facsimile:
Contact Person:
Jonathan S. Kahan, Esq.
Regulatory Counsel
Hogan & Hartson L.L.P.
555 Thirteenth Street, N.W.
Washington, D.C. 20004-1109
Telephone: (202) 637-5794
Facsimile: (202) 637-5910
Email: JSKahan@HHLaw.com November 14, 2003
Date Prepared:
Name of Device and Name/Address of Sponsor
Trade/Proprietary Name: Radiancy Acne System with ClearTouch™ Light Unit Assembly
Dermatological Laser and Light Unit Assembly Common Name:
1
KO32205 2/2
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 Ravve Street Industrial Park Yavne, Israel
Predicate Devices
ClearLight Phototherapy System, Model CT 420
Intended Use / Indications for Use
The Radiancy Acne System with ClearTouch™ Light Unit Assembly ("Radiancy Acne System") is intended to provide phototherapeutic light to the body. The Radiancy Acne System is generally indicated to treat dermatological conditions. The Radiancy Acne System is specifically indicated to treat mild and moderate inflammatory acne which includes treatment of pustular inflammatory acne in patients with Fitzpatrick skin types I-IV.
Technological Characteristics
The ClearTouch LUA is mounted on the hand piece of Radiancy's SpaTouch Photoepilation System (the "SpaTouch"), or on the hair removal / acne hand piece of Radiancy's SkinStation (the "SkinStation"), in order to treat inflammatory acne (the "Radiancy Acne System"). The Radiancy Acne System consists of two green-coated flash lamps. The Radiancy Acne System produces a wavelength spectrum of 430 - 1100 nm with a pulse duration of 35 msec and has a spot size of 22 x 55 mm.
Substantial Equivalence
The Radiancy Acne System has the same intended use and very similar indications for use, principles of operation, and technological characteristics as the ClearLight Phototherapy System, Model CL 420 ("ClearLight System"). The minor differences between the Radiancy Acne System and the ClearLight System do not raise any new issues of safety and effectiveness. Clinical data demonstrates that the Radiancy Acne System treats mild and moderate inflammatory acne which include pustular inflammatory acne in patients with Fitzpatrick skin types I-IV. Thus, the Radiancy Acne System is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
DEC 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Radiancy Ltd. c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, NW Washington, D.C. 20004
Re: K032205
KU3205
Trade/Device Name: Radiancy Acne System with ClearTouch™ Light Unit Asscmbly
Trade/Device Name: Radiancy Acne : a 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: October 24, 2003 Received: October 24, 2003
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or 10 conniner of prof to Hay 20, 2019 11:51 accordance with the provisions of the Federal Food, Drug. de neces that have been recuire approval of a premarket approval application (PMA). and Cosmetic rear (110) that to nevice, subject to the general controls provisions of the Act. The r ou may, therefore, mans of the Act include requirements for annual registration, listing of general econtrols pro resuring 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 If your device is elabilition to vac controls. Existing major regulations affecting your device can may or saily to 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 r read o o a nove 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 or re rar 807), accesses (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.
3
Page 2 - Mr. Jonathan S. Kahan, Esq.
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
To Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1 Indications for Use Form
| 510(k) Number (if known): | KO32205 |
|---|---|
| --------------------------- | --------- |
Radiancy Acne System with ClearTouch™ Light Unit Device Name: Assembly
Indications for Use:
The Radiancy Acne System with ClearTouch Light Unit Assembly ("Radiancy Acne System") is intended to provide phototherapeutic light to the body. The Radiancy Acne System is generally indicated to treat dermatological conditions. The Radiancy Acne System is specifically indicated to treat mild and moderate inflammatory acne which includes pustular inflammatory acne in patients with Fitzpatrick skin types I-IV.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ X
OR
Over-The-Counter Use (Per 21 C.F.R. 801.109)
(Optional Format 1-2-96)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_K632205