(99 days)
Not Found
No
The summary describes a pulsed-light, manually controlled system with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is intended to treat benign pigmented lesions, which is a therapeutic purpose.
No
Explanation: The device is intended to treat benign pigmented lesions, not diagnose them. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it is a "pulsed-light, manually controlled system," indicating it includes hardware components for light emission and control, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat benign pigmented lesions on the skin using pulsed light. IVDs are used to diagnose diseases or conditions by examining samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is a pulsed-light system applied externally to the skin. IVDs typically involve instruments that analyze biological samples.
- Anatomical Site: The device is used on the facial skin, which is an external application for treatment. IVDs analyze internal biological samples.
The device is a therapeutic device used for a dermatological treatment, not a diagnostic device used for in vitro analysis of biological samples.
N/A
Intended Use / Indications for Use
The Facial SkinCare Device is intended for use in dermatology. The Facial SkinCare Device is specifically indicated to treat benign pigmented lesions, including, but not limited to solar lentigines, ephilides (freckles), and mottled pigmentation in patients with Fitzpatrick skin types I-V.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Radiancy Facial SkinCare Device is a pulsed-light, manually controlled system designed to treat benign pigmented lesions.
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)
Not Found
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.
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.
Not Found
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
§ 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
052991
2006 FER I
510(k) SUMMARY
Radiancy (Israel) Ltd. Radiancy Facial SkinCare Device
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: | Margaret Fourte
Director, Clinical and Regulatory Affairs
Radiancy, Inc.
40 Ramland Road
Orangeburg, NY 10972
Telephone: (845) 398-1647
Facsimile: (845) 398-1648
Email: margaret@radiancy.com |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | January 20, 2006 |
Name of Device and Name/Address of Sponsor
| Trade/Proprietary Name: | Radiancy Facial SkinCare Device |
|---|---|
| Common Name: | Pulsed Light System and Light Unit Assembly |
| 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 |
1
K0.52991
Predicate Devices
Radiancy, Inc. SPR System (K033181)
Danish Dermatologic Development A/S Ellipse IPPL ™ (K043255)
Device Description
The Radiancy Facial SkinCare Device is a pulsed-light, manually controlled system designed to treat benign pigmented lesions.
Intended Use / Indications for Use
The Facial SkinCare Device is intended for use in dermatology. The Facial SkinCare Device is specifically indicated to treat benign pigmented lesions, including, but not limited to solar lentigines, ephilides (freckles), and mottled pigmentation in patients with Fitzpatrick skin types I-V.
Technological Characteristics
The Facial SkinCare Device that is the subject of this 510(k) notice is similar to devices already cleared to treat benign pigmented lesions.
Substantial Equivalence
The Radiancy Facial SkinCare Device has the same intended use and one of the same indications for use, same principles of operation and same technological characteristics as the Radiancy SPR System and the Ellipse I PL™, which have already been cleared to treat benign pigmented lesions. The minor differences between the Radiancy Facial SkinCare Device and the predicates do not raise new issues of safety and effectiveness. Thus, the Radiancy Facial SkinCare Device is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services in the USA. The seal is circular and features an abstract eagle design in the center. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Radiancy (Israel) Ltd. c/o Ms. Margaret Fourte Director, Clinical and Regulatory Affairs Radiancy, Inc. 40 Ramland Road South, Suite 10
Re: K052991
Orangeburg, New York 10962
Trade/Device Name: Radiancy Facial SkinCare 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: December 22, 2005 Received: December 23, 2005
FER I
2006
, 1
ત્
Dear Ms. Fourte:
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 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.
3
Page 2 - Ms. Fourte
This letter will allow you to begin marketing your device as described in your Section 510(k) r market 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.
Sincerely yours,
Barbara Buckner
Mark N. Melkerson 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 Indication for Use Form
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K052991 --
Radiancy Facial SkinCare Device Device Name:
Indications for Use:
The Radiancy Facial SkinCare Device is intended for dermatological use. The Facial SkinCare Device is specifically intended to treat benign pigmented lesions, i ablar onlinears botted to solar lentigines, ephilides (freckles), and mottled pigmentation in patients with Fitzpatrick skin types I-V.
, i
く
Prescription Use _____________________________________________________________________________________________________________________________________________________________
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)
| for MXM | |
|---|---|
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(Division Sign-Off)
Division of General Restorative,
and Neurological Devices510(k) N