(231 days)
Not Found
No
The device description and summary of performance studies do not mention any AI or ML components or functionalities. The device is described as a simple LED light therapy device with user-controlled treatment time.
Yes
The device is intended for "treatment of mild to moderate acne," which is a therapeutic purpose.
No
The intended use statement explicitly states the device is "intended for the use in the treatment of mild to moderate acne," and there is no mention of it diagnosing acne or any other condition.
No
The device description explicitly lists multiple hardware components including 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" by applying light to the skin. This is a therapeutic application, not a diagnostic one.
- Device Description: The device uses LEDs to illuminate the skin. It does not involve analyzing biological samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to treat a condition directly on the body.
N/A
Intended Use / Indications for Use
LightStim for Acne Mini, model: LS4AM is intended for Over-The-Counter use for the treatment of mild to moderate acne.
Product codes
OLP
Device Description
LightStim for Acne Mini, model: 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, 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 uscr
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
The participants ranged in age from 11 to 61.
Intended User / Care Setting
Over-The-Counter use / Home
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)
A usability study of this device 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 comprehended 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K131461
Page 1 of 3
JAN - 6 2014
510(k) Summary of Safety & Effectiveness
LED Intellectual Properties, LLC.
Device: LightStim for Acne Mini, Model: LS4AM
1. General Information
・・
Submitter: LED Intellectual Properties, LLC 16552 Von Karman Ave. Irvine. CA 92606
Contact Porson: Steve Marchese Office: (949) 502-4088 Mobile: (865) 394-2427
Date Person: October 10, 2012
2. Names and Code
Device Name: LightStim for Acne Mini, model: L.S4AM
Classification Name: Laser Instrument, Surgical Powered -General and Plastic Surgery -Class 11, OLP
Although this device is not a laser and is intended for OTC use, the manufacturer thinks this is the closet applicable classification name.
1
Page 2 of 3
3. Predicate Devices
.
Quasar Blue Light Therapy System (K093963), Tanda Skincare (K080591), Silkn Blue (121435)
4. Device Description
LightStim for Acne Mini, model: 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, 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 uscr
5. Indications for Use / Intended Use
LightStim for Acne Mini, model: LS4AM is intended for Over-The-Counter use for the treatment of mild to moderate acne.
6. Performance Data
A usability study of this device 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 comprehended risks, warnings, cautions, precautions, and proper use of the device, from the Instruction Manual.
Taking into consideration the table for substantial equivalence 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 Mini has shown substantial equivalence to the predicate devices. Quasar Blue Light System (K093964), Tanda Skincare (K080591), Silkn Blue (121436).
2
| Characteristic | Tanda Skincare
K080591 | Quasar Blue Light Therapy System
493963 | Silk'n Blue
121435 | LightStim for Acne Mini |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Intended Use | Mild to moderate acne. | Mild to moderate acne. | Mild to moderate acne. | Mild to moderate acne. |
| Indications for Use | There is no difference
between the subject and
the predicate device in
regards to indications for
use. | There is no difference
between the subject and
the predicate device in
regards to indications for
use. | There is no difference
between the subject
and the predicate
device in regards to
indications for use | LightStim for Acne Mini
is intended for the use
to treat mild to
moderate acne. |
| Target Population | Women and men with mild
to moderate acne. | Women and men with mild
to moderate acne. | Women and men with
mild to moderate acne. | Women and men with
mild to moderate acne. |
| Output in mW | 50mW/cm2 | 50mW/cm2 | 50mW/cm2 | 50mW/cm2 |
| Treatment Time | Treat breakout areas for 3
minutes, twice daily | 3 minutes per area | 3 to 4 minutes per area | 3 to 4 minutes per area |
| Treatment Area (cm2) | 27 | 10 | 7 | 15.5 |
| Wavelengths (nm) | 415 | 415 | 415 | 415 |
| Where Used | Home | Home | Home | Home |
| Design | Hand-held device | Hand-held device | Hand-held device | Hand-held device |
| Materials | Rigid ABS | Stainless Steel | Rigid ABS | Rigid ABS |
| Electromagnetic
Compatibility | 60601-1-2 | 60601-1-2 | 60601-1-2 | IEC 60601-1-2 |
| Basic safety and
essential performance | IEC 60601-1 | EC 60601-1 | IEC 60601-1 | EC 60601-1 |
| Radiation | Unknown | Unknown | Unknown | IEC 62471/IEC 62471-2 |
The conclusion drawn by LED Intellectual Properties. LLC. based on the comparison table and testing described above, is that the LightStim for Acne Mini raises no new issues of safety and is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an abstract symbol that resembles a person embracing another person.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
January 6, 2014
LED Intellectual Properties, LLC Mr. Steve Marchese CEO 16552 Von Karman Avenue Irvine, California 92606
Re: K131461
Trade/Device Name: 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 02, 2013 Received: December 03, 2013
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.
4
Page 2 - Mr. Steve Marchese, CEO
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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/CDRH/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/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 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Binita S. Ashar 2014.01.06 8-29 -05.00
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(K) Number (if known)
Devioe Name LightStim for Acne Mini
Indications for Use
LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.
Prescription Use_
Over-The-Counter Use -X-
(Per 21 CFR 801. 109)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
OR
Conournence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogden -S
2014.01-03 15:49:51
-05'00"
(Division Sign-off) for BSA
Division of Surgical Devices
510(k) Number __K131461