(206 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on LED light emission and user-controlled settings, with no mention of any computational or learning capabilities.
Yes
Explanation: The device is intended to reduce periorbital wrinkles, which is a therapeutic purpose.
No
The device is intended to reduce periorbital wrinkles by emitting LED light energy and is used "Over The Counter patient usage" for treatment, not for diagnosis.
No
The device description clearly states it is a handheld device with physical components like an ABS plastic housing, stainless steel retainer, polycarbonate lens, LEDs, and a battery. It is a hardware device that emits light energy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "specifically reduce periorbital wrinkles" by emitting LED light energy. This is a therapeutic or cosmetic application, not a diagnostic one.
- Device Description: The description details a handheld device emitting light, not a device that analyzes biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The StarLite-LM does not fit this description.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
79-GEX, OHS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over The Counter patient usage
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)
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.
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
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
200 South Garfield Ave
Suite 318
Alhambra, Calif.
91801 |
|-----------------|---------------------------------------------------------------------------------------------|
| Contact Person: | C D Feak
President
PS Advanced Engineering |
PS Advanced Engineering 200 South Garfield Ave Suite 318 Alhambra, Calif. 91801
Summary Preparation Date: 5 August 2009
- 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.
1
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.
2
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
3
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 (800) 638-2041 or (301) 796-7100 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
4
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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