(51 days)
Not Found
No
The summary describes a phototherapy device that uses light to treat acne and does not mention any AI or ML components or functionalities.
Yes
The device is intended to provide phototherapeutic light to the body and is indicated to treat dermatological conditions, specifically mild to moderate inflammatory acne vulgaris. Treatments for medical conditions are considered therapeutic.
No
The device is intended to provide phototherapeutic light to treat dermatological conditions like acne vulgaris, which is a therapeutic function, not a diagnostic one. It doesn't mention any diagnostic capabilities.
No
The device description clearly outlines hardware components (flash lamps, hand piece, light unit assembly) 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 vulgaris. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a light-emitting system designed for external application to the skin. This aligns with a therapeutic device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or examine specimens (blood, urine, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) for treatment.
N/A
Intended Use / Indications for Use
The Radiancy Acne System with ClearTouch™ Light Unit Assembly ("Radiancy Acre 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 to moderate inflammatory acne vulgaris which includes pustular inflammatory acne, in patients with Fitzpatrick skin types I-VI.
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 acne vulgaris (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
Not Found
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 to moderate inflammatory acne vulgaris in all skin types with only minor side effects.
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
05/268 1 of 2
JUL 6 - 2005
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 Rave Street
Industrial Park |
|---------------|----------------------------------------------------------------|
| | Yavne
Israel |
| Telephone: | +972-8-9438010 |
| Facsimile: | +972-8-9438020 |
| 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 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | April 27, 2005 |
Name of Device and Name/Address of Sponsor
| Trade/Proprietary Name: | Radiancy Acne System with ClearTouch™ Light Unit Assembly |
|---|---|
| Common Name: | Dermatologic Intense Pulse Light (IPL) System |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery |
| and in dermatology (21 C.F.R. § 878.4810) |
- Radiancy (Israel) Ltd. Manufacturing Facility: 9 Gan Rave Street Industrial Park Yavne, Israel
| Establishment | |
|---|---|
| Registration Number: | 9616256 |
| Owner/operator number: | 9040071 |
, I
1
KOS128 2 of 2
Predicate Devices
Radiancy Acne System with ClearTouch™ Light Unit Assembly
ClearLight Phototherapy System, Model CT 420
Intended Use / Indications for Use
The Radiancy Acne System with ClearTouch™ Light Unit Assembly ("Radiancy Acre 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 to moderate inflammatory acne vulgaris which includes pustular inflammatory acne, in patients with Fitzpatrick skin types I-VI.
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 acne vulgaris (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 Indiancy Acne System with ClearTouch™ Light Unit Assembly and the ClearLight Phototherapy System, Model CL 420 ("ClearLight System"). The minor differences between the Radiancy Acne System and the ClearLight System do not raise new issues of safety and effectiveness. Clinical data demonstrates that the Radiancy Acne System treats mild to moderate inflammatory acne vulgaris in all skin types with only minor side effects. Thus, the Radiancy Acne System is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of the department. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 6 - 2005
Radiancy Ltd. C/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P 555 13" Street N.W. Washington, District of Columbia 20004-1109
Re: K051268
K031200
Trade/Device Name: Radiancy Acne System with ClearTouch™ Light Unit Assembly 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: May 16, 2005 Received: May 16, 2005
Dear Mr. Kahan, Esq:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave 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 101 use stated in the encreative to regists of the Medical Device Amendments, or to commerce pror to May 20, 1978, as accordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (11ct) that do novice, subject to the general controls provisions of the Act. The r ou may, mercere, mains of the Act include requirements for annual registration, listing of general controll pro receive, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is elassified (see as a ) throls. Existing major regulations affecting your device TDA it may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Cours of Features concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least be advised that I Dri 3 issual.co or cour device complies with other requirements of the Act that I DA has made a develiminations administered by other Federal agencies. You must of any I cach statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quiany of trol 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) This icter will anow your to ough finding of substantial equivalence of your device to a legally premarket nonnounce. "The sults 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 If you desire specific as a moliance at (240) 276-0115 . Also, please note the regulation entitled, connact the Office of Computers on (Et notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number (800) 638-2041 or 1911) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Muriam C. Provost
Miriam C. Provost, Ph.D. Acting 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): K051268
Device Name:
Radiancy Acne System with ClearTouch™ Light Unit 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 System 71s michded to provide provide conditions. The Radiancy Acne System is Is gelicially indicated to treat mild to moderate inflammatory acne vulgaris which includes pustular inflammatory acne, in patients with Fitzpatrick skin types I-VI.
Prescription Use __ X_
OR
Over-The-Counter Use_ (Per 21 C.F.R. 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K05/268
\\PH - 69039/0002 - 18635 v1