(23 days)
Not Found
No
The summary explicitly states the device is "technologically identical" to the predicate device and makes no mention of AI or ML.
Yes
The device is described as "intended for providing light therapy to the body" and "specifically indicated for treatment of pigmented and vascular lesions," which are therapeutic applications.
No
The device description states its purpose is for "providing light therapy" and "treatment of pigmented and vascular lesions," which are therapeutic rather than diagnostic functions.
No
The device description explicitly states it is a "pulsed light device," which is a hardware component used for light therapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions." This describes a therapeutic device that acts on the body directly, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description reinforces the therapeutic nature of the device, focusing on light therapy for treating lesions.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information about a patient's health status.
IVD devices are used in vitro (outside the body) to examine specimens and provide information for diagnosis, monitoring, or screening. This device operates in vivo (on the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions.
Product codes
GEX
Device Description
The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions. The SPR has the same intended use, with similar indications for use, and is technologically identical to the cleared SkinStation with respect to the operation and function of the SkinStation's pigmented and vascular lesions module.
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)
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 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
OCT 2 4 2003
Kossia I of 2
510(k) SUMMARY
Radiancy (Israel) Ltd.'s SPR System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Radiancy (Israel) Ltd. 9 Gan Ravve Street Industrial Park Yavne lsrael Telephone: +972-8-9438010 Facsimile: +972-8-9438020 Jonathan S. Kahan, Esq. Contact Person:
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:
Name of Device and Name/Address of Sponsor
| Trade/Proprietary Name: | SPR™ System |
|---|---|
| Common Name: | Pulsed Light System |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR § 878.4810) |
| Address of Manufacturing Facility: | Radiancy (Israel) Ltd. |
| 9 Gan Ravve Street | |
| Industrial Park | |
| Yavne, Israel |
1
K031891 2 of 2
Establishment Registration Number: Owner/operator number:
9616256 9040071
Predicate Devices
Radiancy's SkinStation® System (K030897)
Intended Use / Indications for Use
The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions.
Technological Characteristics and Substantial Equivalence
The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions. The SPR has the same intended use, with similar indications for use, and is technologically identical to the cleared SkinStation with respect to the operation and function of the SkinStation's pigmented and vascular lesions module.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
OCT 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Radiancy (Israel) Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109
Re: K033181
Trade/Device Name: SPR™ System 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: September 30, 2003 Received: October 1, 2003
Dear Mr. Kahan:
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 - Mr. Jonathan S. Kahan
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
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):
SPR™ System Device Name:
Indications for Use:
The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use_ (Per 21 C.F.R. 801.109)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
(Optional Format 1-2-96)
510(k) Number K033181
\\PH - 69039/0002 - 13460 v1