(90 days)
The SkinStation is a pulsed light device intended for hair removal and for treatment of pigmented and vascular lesions.
The SkinStation is a pulsed light device intended for hair removal and treatment of pigmented and vascular lesions. When operated in the hair removal mode, the Skin Station is identical to the previously cleared SpaTouch, except that it is now housed with the SPR module for treating pigmented and vascular lesions. When operated in the pigmented and vascular lesions mode (i.e., using the SPR handpiece), the SkinStation has the same intended use, with similar indications for use, and is technologically similar to the cleared Quantum, with a few exceptions which do not raise new issues of safety and effectiveness. In addition, the SkinStation has the same intended use, with similar indications for use, and is technologically similar to the previously cleared MBC's Prolite and Palomar's EsteLux when operated in the SPR mode
I am sorry, but the provided text does not contain any information about acceptance criteria or a study to prove the device meets acceptance criteria. The document is a 510(k) summary for the Radiancy SkinStation™ System, primarily discussing its substantial equivalence to predicate devices for its intended use of hair removal and treatment of pigmented and vascular lesions. It does not detail specific performance metrics, clinical study designs, sample sizes, expert qualifications, or ground truth establishment.
{0}------------------------------------------------
JUN 1 9 2003
510(k) SUMMARY
Radiancy (Israel) Ltd.'s SkinStation™ 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
March 19, 2003 Date Prepared:
Name of Device and Name/Address of Sponsor
| Trade/Proprietary Name: | SkinStation™ System |
|---|---|
| Common Name: | Pulsed Light System |
| Classification Name: | Laser surgical instrument for use in general andplastic surgery and in dermatology (21 CFR §878.4810) |
{1}------------------------------------------------
| Address of Manufacturing Facility: | Radiancy (Israel) Ltd. |
|---|---|
| 9 Gan Ravve Street | |
| Industrial Park | |
| Yavne, Israel | |
| Establishment Registration Number: | 9616256 |
| Owner/operator number: | 9040071 |
Predicate Devices
Radiancy's SpaTouch Hair Removal System Lumenis IPL Quantum SR Medical Bio Care Sweden's Prolite Palomar's EsteLux.
Intended Use / Indications for Use
The SkinStation is a pulsed light device intended for hair removal and for treatment of pigmented and vascular lesions.
Technological Characteristics and Substantial Equivalence
The SkinStation is a pulsed light device intended for hair removal and treatment of pigmented and vascular lesions. When operated in the hair removal mode, the Skin Station is identical to the previously cleared SpaTouch, except that it is now housed with the SPR module for treating pigmented and vascular lesions. When operated in the pigmented and vascular lesions mode (i.e., using the SPR handpiece), the SkinStation has the same intended use, with similar indications for use, and is technologically similar to the cleared Quantum, with a few exceptions which do not raise new issues of safety and effectiveness. In addition, the SkinStation has the same intended use, with similar indications for use, and is technologically similar to the previously cleared MBC's Prolite and Palomar's EsteLux when operated in the SPR mode
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and care. The profiles are black against a white background.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2003
Radiancy (Israel) Ltd. c/o Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109
Re: K030897 Trade/Device Name: SkinStation™ 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: March 21, 2003 Received: March 21, 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 - 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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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): K030897
Device Name:
SkinStation™ System
Indications for Use:
The SkinStation is a pulsed light device intended for hair removal and 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 X
OR
Miriam C. Provost
(Optional Format 1-2-96)
(Per 21 C.F.R. 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K030897
\\DC - 69039/0002 - 1700690 v1
§ 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.