(168 days)
Not Found
No
The device description and performance studies focus on the physical components (LEDs, power supply) and user comprehension, with no mention of AI or ML technologies.
Yes
The device is intended for the treatment of mild to moderate acne, which is a therapeutic purpose.
No
The "Intended Use / Indications for Use" section clearly states that the device is "intended for the use in the treatment of mild to moderate acne," not for diagnosis.
No
The device description explicitly lists hardware components such as LEDs, a hand piece, a printed circuit board, an on/off switch, a resistor, a receiver jack, and a power supply.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of mild to moderate acne." This is a therapeutic use, not a diagnostic one.
- Device Description: The device uses light to interact with the skin. It does not involve testing samples of biological material (like blood, urine, or tissue) outside of the body, which is the hallmark of an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
In vitro diagnostic devices are used to examine specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device directly treats a condition on the body's surface.
N/A
Intended Use / Indications for Use
LightStim for Acne/ LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.
Product codes (comma separated list FDA assigned to the subject device)
OLP
Device Description
LightStim for Acne / LightStim for Acne Mini, model: LS4A/LS4AM is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide illumination which comes in contact with the skin. The device components include LED's of 415nm and 630nm, a hand piece, a printed circuit board, an on/off switch, a resistor, a receiver jack in the hand piece to plug a power supply into and a separate AC to DC (9 volt) power supply. Treatment time is recommended to be three to four minutes and is controlled by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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
A usability study was performed on the LightStim for Acne Mini K131461. which is the exact same device but with 415nm Blue LEDs only. This study was conducted with 40 participants. The participants ranged in age from 11 to 61. The results showed that the participants adequately decided whether or not to use the device for their level of acne, and showed that users comprehend risks, warnings, cautions, precautions, and proper use of the device, from the Instruction Manual.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A usability study was performed on the LightStim for Acne Mini K131461. which is the exact same device but with 415nm Blue LEDs only. This study was conducted with 40 participants. The participants ranged in age from 11 to 61. The results showed that the participants adequately decided whether or not to use the device for their level of acne, and showed that users comprehend risks, warnings, cautions, precautions, and proper use of the device, from the Instruction Manual.
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.
Ultra Renew Plus (K132833), LightStim for Acne Mini (K131461)
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above and below them, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 29, 2015
LED Intellectual Properties, LLC Mr. Steve Marchese Chief Executive Officer 16552 Von Karman Avenue Irvine, California 92606
Re: K142246
Trade/Device Name: LightStim for Acne/ LightStim for Acne Mini 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: OLP Dated: December 23, 2014 Received: December 29, 2014
Dear Mr. Marchese:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142246
Device Name
LightStim for Acne/ LightStim for Acne Mini
Indications for Use (Describe)
LightStim for Acne/ LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary of Safety & Effectiveness
LED Intellectual Properties, LLC.
Device: LightStim for Acne & LightStim for Acne Mini
1. General Information
Submitter: LED Intellectual Properties, LLC 16552 Von Karman Ave. Irvine, CA 92606
Contact Person: Steve Marchese Office: (949) 502-4088 Mobile: (949) 394-2427
Date Prepared: August 1, 2014
2. Names and Code
Device Name: LightStim for Acne/LightStim for Acne Mini, model: LS4A/LS4AM
Classification Name: Laser Instrument, Surgical Powered - General and Plastic Surgery - Class II, OLP
Although this device is not a laser and is intended for OTC use, the manufacturer thinks this is the closet applicable classification name.
3. Predicate Devices
Ultra Renew Plus (K132833) and LightStim for Acne Mini (K131461
4. Device Description
LightStim for Acne / LightStim for Acne Mini, model: LS4A/LS4AM is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide illumination which comes in contact with the skin. The device components include LED's of 415nm and 630nm, a hand piece, a printed circuit board, an on/off switch, a resistor, a receiver jack in the hand piece to plug a power supply into and a separate AC to DC (9
4
volt) power supply. Treatment time is recommended to be three to four minutes and is controlled by the user.
5. Indications for Use / Intended Use
LightStim for Acne/LightStim for Acne Mini, model: LS4A/LS4AM is intended for Over-The-Counter use for the treatment of mild to moderate acne.
6. Performance Data
A usability study was performed on the LightStim for Acne Mini K131461. which is the exact same device but with 415nm Blue LEDs only. This study was conducted with 40 participants. The participants ranged in age from 11 to 61. The results showed that the participants adequately decided whether or not to use the device for their level of acne, and showed that users comprehend risks, warnings, cautions, precautions, and proper use of the device, from the Instruction Manual.
Taking into consideration the (attached) table for substantial equivalence evidencing both predicates being handheld, OTC, utilizing blue light and K132833 also utilizing red light, which poses no new issues of safety or effectiveness as the active wavelength in the treatment of mild to moderate acne is in the blue region of light, thus evidencing the primary objective of acne treatment are common in all of theses devices, and after an analysis of safety, indications, intended uses, performance, features, technological properties and methods of operations. LED Intellectual Properties, LLC believes that LightStim for Acne/LightStim for Acne Mini has shown substantial equivalence to the predicate devices Ultra Renew Plus (K132833) and LightStim for Acne Mini (K131461.
The conclusion drawn by LED Intellectual Properties, LLC is that LightStim for Acne/ LightStim for Acne Mini raise no new issues of safety and are substantially equivalent to the predicate devices.