(82 days)
No
The device description details a simple LED-based light therapy device with a basic on/off switch and power supply. There is no mention of any computational processing, algorithms, or data analysis that would indicate the presence of AI or ML. The clinical study described is a standard performance evaluation, not a study of an AI/ML algorithm's performance.
Yes
The device is intended for the "treatment of full-face wrinkles", which indicates a therapeutic purpose. The summary of performance studies also details the reduction in wrinkle severity, further supporting its therapeutic claim.
No
The device is described as an over-the-counter hand-held device intended for the treatment of full-face wrinkles, not for diagnosis. Its description and clinical study focus on wrinkle reduction.
No
The device description clearly outlines hardware components such as LEDs, a hand piece housing, a printed circuit board, a switch, a receiver jack, and a power supply. It is a physical device that emits light.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the use in the treatment of full-face wrinkles." This is a therapeutic use, not a diagnostic one. IVDs are used to diagnose diseases or conditions by examining samples from the body (like blood, urine, or tissue).
- Device Description: The device description details a light-emitting device for direct application to the skin. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, preparing, or analyzing biological specimens, which are fundamental to IVDs.
The device is a therapeutic device intended for a cosmetic or medical treatment (wrinkle reduction) applied directly to the body, not for diagnosing a condition by analyzing samples.
N/A
Intended Use / Indications for Use
The LightStim for Wrinkles is an Over-The-Counter handheld device intended for the use in the treatment of full-face wrinkles.
Product codes
OHS
Device Description
The LightStim for Wrinkles is a hand-held device with a power output of 65mW/cm2, consisting of light emitting diodes (LED's) that emit Low and Sub IR light for direct exposure to the skin. The components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelength, a (non-flammable plastic) hand piece housing, a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with a resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC (9-volt) power supply. Treatment time is recommended to be 3 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
full-face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Usability Study: 50 participants; goals were: (1) to attract participants that represented the "intended users" of the device; (2) to determine if consumers could correctly self-select using the Packaging labeling only; (3) to test consumer knowledge of the Packaging labeling and Instruction Manual; (4) to have consumers demonstrate their ability to adhere to what they had read in the Instruction Manual and actually operate and care for the device correctly. All four goals of the Study were met. indicating that the LightStim for Wrinkles K120775 has similar consumer usability to the Light for Wrinkles K101190.
Clinical Study: An 8-week Clinical Study with 40 participants was conducted with the premise that the LightStim for Wrinkles K120775 will deliver similar results in full-face wrinkle reduction to the Light for Wrinkles K101190 that was clinically tested for periorbital wrinkle reduction. The Study utilized the Fitzpatrick Wrinkle Scale (FWS) to judge wrinkle severity on a 1 through 9 basis. The outcome of the K120775 Clinical Study was that the participant's average fullface wrinkles base line was 5.73 on the FWS and at the end of the 8-weeks of treatment the average score revealed a reduction in full-face wrinkles to 4.54 on the scale. Further reduction to 4.2 on the scale was found at the 3-month follow-up after cessation of treatment.
Key Metrics
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
510(k) Summary of Safety and Effectiveness
LED Intellectual Properties, LLC.
Device: LightStim for Wrinkles K120775
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
- General Information
Date: March 8, 2012
Submitter:
LED Intellectual Properties, LLC . 16552 Von Karman Avenue Irvine, Calif. 92606 Fax: (949) 502-4090 Tel: (949) 502-4088 Email: steve@lightstim.com cell: (949) 394-2427 Contact: Steve Marchese
- Device name and code
Device Proprietary Name: LightStim for Wrinkles Class Name: Laser Instrument for General and Plastic Surgery Classification Code: OHS, Class II Indications: Light Based Over-The-Counter Wrinkle Reduction
- Predicate Devices
LED Intellectual Properties, LLC - Light for Wrinkles (K101190)
- Device Description
The LightStim for Wrinkles is a hand-held device with a power output of 65mW/cm2, consisting of light emitting diodes (LED's) that emit Low and Sub IR light for direct exposure to the skin. The components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelength, a (non-flammable plastic) hand piece housing, a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with a resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC (9-volt) power supply. Treatment time is recommended to be 3 minutes and is controlled by the user.
1
5. Indications for Use
The LightStim for Wrinkles is an Over-The-Counter handheld device intended for the use in the treatment of full-face wrinkles.
- Substantial Equivalency
(a) The "LightStim for Wrinkles" K120775 is a new name for the predicate device "Light for Wrinkles". Substantial Equivalency Comparison chart is attached separately.
(b) (1) A Usability Study (equivalent to the Study conducted under K101190) with the following four goals was conducted utilizing 50 participants: (1).to attract participants that represented the "intended users" of the device; (2) to determine if consumers could correctly self-select using the Packaging labeling only; (3) to test consumer knowledge of the Packaging labeling and Instruction Manual; (4) to have consumers demonstrate their ability to adhere to what they had read in the Instruction Manual and actually operate and care for the device correctly. All four goals of the Study were met. indicating that the LightStim for Wrinkles K120775 has similar consumer usability to the Light for Wrinkles K101190.
(b) (2) An 8-week Clinical Study (equivalent to the Clinical Study conducted under K101190) with 40 participants was conducted with the premise that the LightStim for Wrinkles K120775 will deliver similar results in full-face wrinkle reduction to the Light for Wrinkles K101190 that was clinically tested for periorbital wrinkle reduction. The Study utilized the Fitzpatrick Wrinkle Scale (FWS) to judge wrinkle severity on a 1 through 9 basis. The outcome of the K120775 Clinical Study was that the participant's average fullface wrinkles base line was 5.73 on the FWS and at the end of the 8-weeks of treatment the average score revealed a reduction in full-face wrinkles to 4.54 on the scale. Further reduction to 4.2 on the scale was found at the 3-month follow-up after cessation of treatment.
(b) (3) The conclusion drawn by LED Intellectual Properties LLC, based on the facts that the LightStim for Wrinkles K120775 produced similar results in the Usability Study and similar results in the Clinical Study to the Light for Wrinkles K101190 is that the LightStim for Wrinkles raises no new issues of safety and has proven efficacy in the treatment of full-face wrinkles.
2
| 6(a) Substantial Equivalence Comparision | |||
|---|---|---|---|
| Characteristic | Light for Wrinkles K101190 | LightStim for Wrinkles K120775 | |
| Intended Use | The Light for Wrinkles is an | ||
| Over-The-Counter handheld | |||
| device intended for the use in | |||
| treatment of periorbital | |||
| wrinkles. | The Light for Wrinkles is an | ||
| Over-The-Counter hand-held | |||
| device intended for the use in | |||
| treatment of full-face wrinkles. | |||
| Indications for Use | Periorbital Wrinkles | Full-Face Wrinkles | |
| Target Population | Women and men with | ||
| periorbital wrinkles | Women and men with full-face | ||
| wrinkles | |||
| Anatomical Sites | Periorbital Area | Entire Face | |
| Where Used | Home | Home | |
| Energy Used and/or Delivered | 9-volt DC power | ||
| transformer/approx. | |||
| 65mW/cm2 | 9-volt DC power | ||
| transformer/approx. | |||
| 65mW/cm2 | |||
| Usability Study with Labeling | |||
| Comprehension and self- | |||
| selection conducted, with both | |||
| exhibiting results of | |||
| effectiveness and safety. | Usability Study with Labeling | ||
| Comprehension and self- | |||
| selection conducted, with both | |||
| exhibiting results of | |||
| effectiveness and safety | |||
| Human factors | |||
| Design | Hand-held device | ||
| Clinical Study of 100% of the 44 | |||
| participants exibiting a | |||
| reduction in fine lines and | |||
| wrinkles in the periorbital area. | Hand-held device | ||
| Clinical Study of 100% of the 40 | |||
| participants exibiting a | |||
| reduction in facial wrinkles in | |||
| the periorbital area. | |||
| Performance | Power is approximately | ||
| 65mW/cm2. | Power is | ||
| approximately 65mw/cm2. | |||
| Standards Met | IEC-60601-1-2, IEC-60601-1, ISO | ||
| 10993, ISO-13485 | IEC-60601-1-2, IEC-60601-1, ISO | ||
| 10993, ISO-13485 | |||
| Materials | glass polymer, plastic, metal | glass plymer, plastic, metal | |
| glass polymer, ABS Lustran 348 | |||
| plastic | |||
| Compatibility with the Environment and Other Devices | glass polymer and plastic | ||
| IEC-60601-1-2 | IEC-60601-1-2 | ||
| Power Supply delivering a safe | |||
| 9-volts DC to the hand-held | |||
| device. IEC-60601-1-2, and IEC- | |||
| Electrical Safety | 60601-1 | ||
| Mechanical Safety | IEC-60601-1 | ||
| Thermal Safety | IEC-62471 | ||
| Radiation Safety | IEC-62471 |
:
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image contains a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the bottom and "USA" at the top.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 4 2012
LED Intellectual Properties % Mr. Steve Marchese CEO 16552 Von Karman Avenue Irvine . California 92606
Re: K120775
Trade/Device Name: LightSlim for Wrinkles Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: Class II
Product Code: OHS Dated: May 11, 2012 Received: May 22, 2012
Dear Mr. Steve 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. Marchese
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 (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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K120775, 1 of 1
Indications for Use Statement
| 510(k)
Number
| (if known) | K120775 |
|---|---|
| Device Name | LightStim for Wrinkles |
__ and__
Indications for Use
The LightStim for Wrinkles is an over-the-counter hand-held device intended for the use in the treatment of full-face wrinkles
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801. 109) OR
. Over-The-Counter Use
Nil RPOgden for nkm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
. 510(k) Number K120775