STARLIGHT, MODEL PD9012

K073317 · F.P. Rubinstein Y Cia S.R.L. · GEX · Sep 3, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073317
• Device Name: STARLIGHT, MODEL PD9012
• Applicant: F.P. Rubinstein Y Cia S.R.L.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

STARLIGHT® is a light-based system intended for the removal of unwanted hair (permanent hair reduction*) and the treatment of benign cutaneous, vascular and pigmentary lesions in skin phototypes I to V of the Fitzpatrick Table. *Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

Device Story

STARLIGHT® is an intense pulsed light (IPL) system delivering light in the 530-1200 nm range. The device consists of a central module, LCD/keyboard interface, and two handpieces containing a flash lamp, light-conducting glass with filter, and shooting buttons. It features an integrated hydraulic cooling system. The system is controlled by an internal microcontroller. It is intended for use by healthcare professionals in clinical settings to treat benign skin lesions and perform hair reduction. The provider uses the interface to configure treatment parameters; the device delivers light pulses to the target area. The cooling system manages thermal effects on the skin. Clinical benefit includes the removal of unwanted hair and the treatment of specific benign cutaneous, vascular, and pigmentary conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance similarities to the predicate device.

Technological Characteristics

Intense Pulsed Light (IPL) system; 530-1200 nm wavelength range. Features include flash lamp, light-conducting glass with filter, and integrated hydraulic cooling system. Controlled by an internal microcontroller with LCD and soft-touch keyboard interface. Compact, self-contained form factor.

Indications for Use

Indicated for removal of unwanted hair (permanent hair reduction) and treatment of benign cutaneous, vascular, and pigmentary lesions in patients with Fitzpatrick skin phototypes I to V.

Regulatory Classification

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.

Predicate Devices

• Skin Station™ System (K030897)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the numbers '073319'. The handwriting appears to be somewhat stylized, with distinct shapes for each character and number.

SEP - 3 2008 F. P. Rubinstein y Cía. SRL 510(k) Submission STARLIGHT® - Pulsed Light Device

## SECTION G - 510(k) SUMMARY

## 510(k) Summary of Safety and Effectiveness for STARLIGHT®

| Applicant | F. P. Rubinstein y Cía. SRL |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | David Luque 519 - X5004AKM Córdoba, Argentina |
| Contact Person | Haydée N. Demarco (Official Correspondent) |
| Telephone / Fax | [phone] / [phone] |
| Preparation<br>Date | October 29th, 2007 |
| Device Trade<br>Name | STARLIGHT® |
| Common Name | Intense Pulsed Light System |
| Classification<br>Name | Laser surgical instrument for use in General and Plastic<br>Surgery and Dermatology - 21 CFR §878.4810<br>Product Code: GEX<br>Panel: 79<br>Class: II |
| Legally<br>marketed<br>Predicate<br>Device | Skin Station™ System, K030897 |
| System<br>Description | STARLIGHT® is a light-based system that delivers Intense<br>Pulsed Light in the region of 530 to 1200 nanometers of the<br>Electromagnetic Spectrum. The system has been designed<br>to be compact and self-contained, comprising:<br>-A central module<br>-An LCD and soft-touch keyboard interface<br>-Two application handpieces housing a flash lamp, a light<br>conducting glass w/filter and two shooting buttons<br>-An integrated Hydraulic Cooling System<br>The system's electronics and user interface are controlled<br>by a microcontroller. |
| Intended Use | STARLIGHT® is a light-based system intended for the<br>removal of unwanted hair (permanent hair reduction*) and<br>the treatment of benign cutaneous, vascular and<br>pigmentary lesions in skin phototypes I to V of the<br>Fitzpatrick Table.<br>*Permanent hair reduction is defined as a long-term stable reduction in<br>the number of hairs regrowing after a treatment regime. |
| Technological<br>Characteristics | The technological characteristics, performance, intended<br>use, indications, operation and application of STARLIGHT®<br>are similar to those of the predicate device; therefore no<br>new questions on safety and effectiveness are raised and a<br>substantial equivalence is determined. |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its wing, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 3 2008

F.P. Rubinstein y Cía. SRL % Haydée N. Demarco David Luque 519 Cordoba X5004 AKM Argentina

Re: K073317 Trade/Device Name: STARLIGHT® Regulation Number: 21 CFR 878.4810 Regula.ion Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 4. 2008 Received: August 8, 2008

Dear Haydée Demarco:

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

{2}------------------------------------------------

Page 2 - Haydée N. Demarco

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.

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 Iogal] marketed predicate device results in a classification for your device and thus, perceits 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 Center for Devices and Radiological Health's (CDRH's) Office of Comrobile [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## INDICATIONS FOR USE STARLIGHT®

510(k) Number: K073317

Device Name: STARLIGHT®

Indications for Use:

STARLIGHT® is a light-based system intended for the removal of unwanted hair (permanent hair reduction*) and the treatment of benign cutaneous, vascular and pigmentary lesions in skin phototypes I to V of the Fitzpatrick Table.

*Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR (per 21 CFR 801.109)

Over-the-counter Use

(Please do not write below this line – continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Olo

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** 10673317