(386 days)
Not Found
No
The device description and performance studies focus on light therapy and safety standards, with no mention of AI or ML.
Yes.
The device is indicated for the "treatment of mild to moderate acne," which explicitly states a therapeutic purpose.
No.
The device is indicated for the treatment of mild to moderate acne, not for diagnosis.
No
The device description clearly outlines hardware components including a rechargeable controller, therapy heads with LEDs, control buttons, connectors, and sensors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "treatment of mild to moderate acne." This is a therapeutic use, not a diagnostic one. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device uses light therapy (blue light at 415nm) applied externally to the skin. This is a physical treatment method, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, preparing, or analyzing biological specimens (like blood, urine, tissue, etc.).
Therefore, the Lustre PRO light system is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Lustre PRO Light System is indicated for the treatment of mild to moderate acne.
Product codes
GEX, OLP
Device Description
The Lustre PRO light system is a small portable non-invasive device, comprising of a rechargeable controller and therapy heads containing light emitting diodes, emitting blue light at a peak wavelength of 415nm, and a Full Width Half Maximum (FWHM) of 15nm.
The therapy heads are designed to be attached to the site of the acne using a disposable polyethylene film impregnated with a medical-grade adhesive. The controller comprises of an LCD graphical user interface, 3 control buttons, a coaxial connector and 3 mini USB connectors. The controller switches the therapy heads on and off and includes a programmable timer, allowing modification of treatment time and indicators for battery level, therapy head status and treatment time remaining. The device contains sensors which monitor the therapy heads and emit audible and visible alarms relating to overheating and disconnection of the therapy heads.
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
Not Found
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
A self-selection and usability study of 71 subjects demonstrated that the labelling and user guide for the Lustre PRO system exceeded comprehension levels determined a priori and demonstrated that the device could be used safely and effectively by lay persons.
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.
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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The profiles are enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2016
Ambicare Health Ltd. c/o Susan D'Arcy iSMART Marketing Services Ltd. 129 Green Lanes, Wylde Green, Sutton Coldfield, Birmingham, GB B735LT West Midlands
Re: K143713 Trade/Device Name: Lustre PRO Light System 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: GEX Dated: November 15, 2015 Received: November 23, 2015
Dear Ms. D'Arcy:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
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 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/Resourcesfor You/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 -S
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) K143713
Device Name Lustre PRO Light System
Indications for Use (Describe)
The Lustre PRO light system is indicated for 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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Image /page/3/Picture/0 description: The image shows the logo for Ambicare Health. The word "ambicare" is written in gray, with a horizontal orange line above the "i" and "c". To the right of the word "ambicare" is a plus sign, also in orange. Below the word "ambicare" is the word "Health" in a smaller font, also in orange.
510(k) Summary
Alba Innovation Centre Alba Campus Livingston EH54 7GA Scotland United Kingdom
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).
Submitter's Name:
Ambicare Health Ltd
Submitter's Address:
Ambicare Health Ltd 10 Lochside Place, Edinburgh, EH12 9RG Scotland, UK
SBDN: SBD158325
User Fee Organisation Number: 297701
Establishment Registration Number:
Still to be established
Contact Person:
Susan D'Arcy
Telephone +44 (0) 7880313315
Date Prepared: December 16th 2014
Date Modified: May 30th 2015
November 13th 2015
Page 1 of 4 K143713-.510k SummaryFINAL-.doc
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Image /page/4/Picture/0 description: The image shows the logo for Ambicare Health. The word "ambicare" is written in gray, with a horizontal orange line above the "care" portion of the word. To the right of the word is an orange plus sign. Below the word "ambicare" is the word "Health" in orange.
Device Trade Name:
Lustre PRO Light System
Device Common Name:
Lustre Pure Light system
Device Classification Information:
| Regulation
Number | Device | Device
Class | Product
Code | Classification
Panel |
|----------------------|----------------------------------------------------------------------------|-----------------|-----------------|---------------------------------|
| 21 CFR
878.4810 | Over the counter powered
light based laser for Acne,
21 CFR 878.4810 | Class 2 | OLP | General &
Plastic
Surgery |
Predicate devices
The Ambicare Health, Lustre PRO Light system is substantially equivalent to the Silk' n Blue (K121435) (Home skin innovations).
Device Description:
The Lustre PRO light system is a small portable non-invasive device, comprising of a rechargeable controller and therapy heads containing light emitting diodes, emitting blue light at a peak wavelength of 415nm, and a Full Width Half Maximum (FWHM) of 15nm.
The therapy heads are designed to be attached to the site of the acne using a disposable polyethylene film impregnated with a medical-grade adhesive. The controller comprises of an LCD graphical user interface, 3 control buttons, a coaxial connector and 3 mini USB connectors. The controller switches the therapy heads on and off and includes a programmable timer, allowing modification of treatment time and indicators for battery level, therapy head status and treatment time remaining. The device contains sensors which monitor the therapy heads and emit audible and visible alarms relating to overheating and disconnection of the therapy heads.
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Image /page/5/Picture/0 description: The image shows the logo for Ambicare Health. The word "ambicare" is written in a gray sans-serif font. Above the word "Health" is a yellow line and a plus sign. The word "Health" is written in a smaller, lighter font than the word "ambicare".
Intended/ Indications Use:
The Lustre PRO light system is indicated for the treatment of mild to moderate acne.
Technological Characteristics:
A comparative review of the Lustre PRO Light System with the predicate devices found that the technologies, mode of operation, and general principles for treatment with this device were substantially equivalent to the predicate device.
Substantial Equivalence:
The Lustre PRO and Silk'n Blue are phototherapy devices that use non thermal blue light energy and are intended for the treatment of mild to moderate acne. They both use identical wavelengths and have identical light outputs. The technological characteristics of the Lustre PRO Light System are similar to the technological characteristics of the listed predicate device. Where there are differences between the Lustre PRO Light System and the predicate device these differences have been negated by non-clinical performance testing. The Lustre PRO light system raises no new questions of safety and efficacy and introduce no new risks.
Non Clinical Performance & Safety Data:
The Lustre PRO Light system complies with IEC 60601-1: "Medical Electrical Equipment Part 1 - General Requirements for Basic Safety and essential performance" IEC/EN 60601-1-2: Collateral Standard: Electromagnetic Compatibility - Requirements and test.
The Lustre Pure Light System has been evaluated against EN62471:Photobiological Safety of Lamps and Lamp Systems" in consideration of maximum possible light exposure to users and the results demonstrate that it poses no risk of retinal injury due to either the blue-light phototoxic effect, or the thermal damage mechanism.
Lustre Pure Light System was assessed with regards to usability for compliance with IEC 62366: Medical devices - Application of usability engineering to medical devices and design verification for compliance with IEC 60601-1-11: General requirements for basic safety and essential performance - Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
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Image /page/6/Picture/0 description: The image shows the logo for Ambicare Health. The word "ambicare" is written in gray, with a yellow line above the "i" and a yellow plus sign to the right of the word. Below the word "ambicare" is the word "Health" in a smaller, lighter font. The logo is simple and clean, and the colors are muted.
In addition, testing and analysis of the adhesive strips have demonstrated compliance to ISO 10993: Biological evaluation of medical devices.
A self-selection and usability study of 71 subjects demonstrated that the labelling and user guide for the Lustre PRO system exceeded comprehension levels determined a priori and demonstrated that the device could be used safely and effectively by lay persons.
Data generated from post market clinical experience does not generate any significant doubts to the similarity of the Lustre acne system to other commercial and clinically tested Blue LED light systems. The data presented is suitable to justify safety and performance of the device in relation to predicate devices with similar technology.
These non-clinical tests demonstrate that the Lustre PRO light system is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate devices.