STAR-LITE -LM, MODEL SL8809

K092460 · Ps Advanced Engineering · OHS · Mar 5, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K092460
• Device Name: STAR-LITE -LM, MODEL SL8809
• Applicant: Ps Advanced Engineering
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Mar 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The StarLite-LM is a hand held device intended for over counter (OTC) patient usage to specifically treat the periorbital wrinkles. The target patient population is identical to that of the predicate device. StarLite-LM emits LED light energy in the red and infrared spectrum.

Device Story

StarLite-LM is a handheld, battery-powered LED device for OTC reduction of periorbital wrinkles. Device features ABS plastic housing, medical-grade stainless steel retainer, and medical-grade polycarbonate lens. Emits high spectral purity LED light in red and infrared wavelengths. Operator selects wavelength via pushbutton on alternate treatment days; treatment duration controlled by user per protocols. Powered by internal lithium-ion battery, rechargeable via wall-mounted AC/DC unit. Device provides localized light therapy; intended for patient self-use at home. Output affects skin tissue; intended to improve appearance of wrinkles.

Clinical Evidence

No clinical data provided. Substantial equivalence based on performance, safety, and effectiveness characteristics analysis compared to predicate device.

Technological Characteristics

Handheld device; ABS plastic housing; medical-grade stainless steel retainer; medical-grade polycarbonate lens. Light source: LED (red and infrared spectrum). Power: Internal lithium-ion battery; external AC/DC wall charger. Homogenous light distribution. No software-based algorithms.

Indications for Use

Indicated for OTC use by patients to reduce periorbital wrinkles.

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

• Omnilux New-U (K072459)

Submission Summary (Full Text)

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# 11777460

MAR - 5 2010

## 510 (k) Summary of Safety and Effectiveness for PS Advanced Engineering StarLite-LM

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and per 21 CFR 807.92

### 1) General Information

| Submitter: | PS Advanced Engineering<br>200 South Garfield Ave<br>Suite 318<br>Alhambra, Calif.<br>91801 |
|-----------------|---------------------------------------------------------------------------------------------|
| Contact Person: | C D Feak<br>President<br>PS Advanced Engineering |

PS Advanced Engineering 200 South Garfield Ave Suite 318 Alhambra, Calif. 91801

Summary Preparation Date: 5 August 2009

2) Names StarLite-LM Device Name: Laser Instrument, Surgical Powered - General and Classification Name: Plastic Surgery - Class II, Gen 79-GEX

Although this device is not a Laser and is intended for Over The Counter use, the manufacturer believes this is the classification name which is most applicable.

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### 3) Predicate Device

Omnilux New-U (K072459)

#### 4) Device Description

StarLite-LM is a handheld ergonomically designed ABS plastic housed device with a locking Medical Grade Stainless Steel retainer holding in place a Medical Grade polycarbonate lens from which high spectral purity LED light in 2 (two) specific wavelengths is emitted. By design the optical output has a high degree of homogenous light distribution. The output wavelengths are user selected via a simple pushbutton on alternate treatment days and are in the visible Red and the Infrared spectrum. StarLite-LM is powered by a built in Lithium lon Battery which can be charged as required via a supplied UL listed AC/DC wall mounted unit. Treatment time for both light outputs is controlled by the operator as per Treatment Protocols listed in User Documentation.

#### 5) Indications for Use

The StarLite-LM is a hand held device intended for Over The Counter patient usage to specifically reduce periorbital wrinkles. The target patient population would be identical to the population of the predicate device. StarLite-LM emits LED light energy in the Red and Infrared region.

#### 6) Performance Data

Based on analysis of the performance, safety and effectiveness characteristics for StarLite-LM, PS Advanced Engineering believes that no significant differences in those specific characteristics exists between the StarLite-LM and the previously approved Photo Therapeutics Limited New-U (K072459).

Therefore StarLite-LM raises no new questions of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR - 5 2010

PS Advanced Engineering % Ms. Wen Yang President 200 South Garfield Ave, Suite 318 Alhambra, California 91801

Re: K092460

Trade/Device Name: Star-Lite-LM. Model SL8809 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OHS Dated: January 29, 2010 Received: February 2, 2010

Dear Ms. Yang:

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. Iisting 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 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

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Page 2 - Ms. Wen Yang

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 yours

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number: K092460

Device Name: StarLite-LM

Indications For Use: The StarLite-LM is a hand held device intended for over counter (OTC) patient usage to specifically treat the periorbital wrinkles. The target patient population is identical to that of the predicate device. StarLite-LM emits LED light energy in the red and infrared spectrum.

Signature

(Division Sign-Off) (Division Sign-cical, Orthopedic, Divises and Restorative Devices

11052460

510(k) Number

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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