1. Flexible silicone panel
1. Controller
1. Power supply and country specific adaptors
1. Adjustable straps (2)
  décoLITE is a home use wearable light emitting diode (LED) phototherapy device.
  The device consists of a flexible silicone panel (1) that contains red (630nm) and near infrared (830nm) light emitting diodes (LEDs), a controller (2) that contains a rechargeable lithium polymer batter, a power supply (3) for charging the battery, and two adjustable straps (4) that hold the panel in place during treatment.
  The LEDs produce red and near infrared (NIR) light in the visible spectrum (Red: 630nm ± 10nm, NIR: 830nm ± 10nm). The device works through a non-thermal mechanism called photobiomodulation. The LEDs produce light at an intensity of 30mW/cm² delivering 18J/cm² per treatment.
  The power supply is used to charge the lithium polymer battery in the décoLITE controller

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the décoLITE LED device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Clinical Effectiveness (Wrinkle Reduction)	Reduction in décolleté lines as measured by the validated Landau et al. (2016) scale.	The mean improvement after treatment was 0.9 points (from a mean baseline wrinkle severity of 2.5). 16 out of 19 subjects (84%) felt their wrinkles had improved.
Clinical Effectiveness (Overall Appearance)	Improvement in the overall appearance of the chest.	16 out of 19 subjects (84%) felt the overall appearance of their chest had improved.
Safety (Adverse Events)	No adverse events reported.	No adverse events were reported.
Electrical Safety	Compliance with relevant IEC standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-2-83, IEC 62133-2).	The device was tested and found to comply with all listed applicable standards.
Eye Safety	Compliance with photobiological safety standards.	The device was tested to and complies with IEC 62471:2006.
Thermal Safety	Acceptable skin and panel temperature changes during treatment.	During a 10-minute treatment, the change in skin temperature was +1°C (mean 35.5°C at end) and the panel surface increased by +1.1°C (mean 34.6°C at end). This implies the changes were within safe limits.
Light Characteristics	Verified output characteristics of the light.	Test results verified the output characteristics of the devices.
Usability/Human Factors	Users can complete tasks by following labeling without posing additional hazards.	All seventeen subjects were able to complete all tasks by following the device's labeling. Observations of tasks not completed precisely as specified were within normal use and did not pose additional hazards.

Study Details:

Sample size used for the test set and the data provenance:
- Clinical Performance Test Set Sample Size: 25 subjects were enrolled, 19 completed the full study treatment course. One subject's results were excluded due to unprotected sun exposure, resulting in 18 subjects effectively analyzed for efficacy.
- Usability/Human Factors Test Set Sample Size: 17 subjects.
- Data Provenance: The study appears to be prospective as it involved enrolling subjects, administering treatment, and then evaluating outcomes. The location of the study is not explicitly stated but implies a clinical setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document primarily describes a patient-reported outcome (subjects "felt their wrinkles had improved" and "felt the overall appearance of their chest had improved") and an objective assessment using a validated scale ("Landau et al. (2016)"). It does not explicitly state the number or qualifications of experts used for establishing the ground truth for the clinical effectiveness endpoints. The "mean baseline wrinkle severity was 2.5 and the mean improvement after treatment was 0.9 points" suggests an objective assessment, likely by a trained clinician or rater using the Landau scale. However, the exact number and qualifications of these raters are not provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method for the clinical effectiveness endpoints. The assessment using the Landau et al. scale likely involved a single or multiple trained raters, but whether consensus or adjudication was used is not specified.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a light-emitting diode (LED) device for wrinkle treatment, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the clinical performance testing assesses the device's standalone effectiveness in reducing wrinkles when used by subjects at home. There is no human-in-the-loop component beyond the subject using the device as instructed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical performance study, the primary effectiveness endpoint was measured using a validated scale developed by Landau et al. (2016), which represents an objective clinical assessment tool. Additionally, patient-reported outcomes (subjects feeling improvement) were used. Safety was assessed by reporting adverse events.
The sample size for the training set:
- The document does not describe a separate "training set" in the context of an algorithm or machine learning model. The clinical study described is a performance study for the device itself, not for training a model.
How the ground truth for the training set was established:
- As there is no mention of a "training set" for an algorithm, this question is not applicable based on the provided text.

Summary

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November 8, 2024

ISMART Developments Ltd Susan D'arcy Owner 129 Green Lanes Wylde Green Birmingham, B73 5LT United Kingdom

Re: K242382

Trade/Device Name: décoLITE LED Device 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: August 12, 2024 Received: August 12, 2024

Dear Susan 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Yan Fu-S
DD
-C

Digitally signed by Yan Fu -S Date: 2024.11.08 12:20:17 -05'00'

for Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K242382

Device Name décoLITE

Indications for Use (Describe)

The decoLITE LED device is an over-the-counter device that is intended for the use in the treatment of wrinkles in the decolletage area.

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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510(k) Summary

K242382

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).

Submitter's Name:	iSMART Developments LTD
Submitter's Address:	129 Green Lanes, Wylde Green, Birmingham, B73 5LT UnitedKingdom
Contact Person:	Susan D'Arcy
Telephone:	+44 (0) 7880313315
Date Prepared:	October 9, 2024
Device Trade Name:	décoLITE Light-Emitting Diode (LED) Device (TN2037)
Common Name:	Light Based Over the Counter Wrinkle Reduction
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand in dermatology
Regulation Number:	21 CFR 878.4810
Product Code:	OHS
Review Panel:	General & Plastic Surgery

Predicate Device

K191629	faceLITE LED Mask
---------	-------------------

Intended Use

The décoLITE light emitting diode (LED) device emits light energy in the red and near infrared (NIR) regions of the light spectrum and is intended for the treatment of wrinkles in the décolletage area.

Device Description

The décoLITE device consists of:

1. Flexible silicone panel
1. Controller
1. Power supply and country specific adaptors
1. Adjustable straps (2)

décoLITE is a home use wearable light emitting diode (LED) phototherapy device.

The device consists of a flexible silicone panel (1) that contains red (630nm) and near infrared (830nm) light emitting diodes (LEDs), a controller (2) that contains a rechargeable lithium polymer batter, a power supply (3) for charging the battery, and two adjustable straps (4) that hold the panel in place during treatment.

The LEDs produce red and near infrared (NIR) light in the visible spectrum (Red: 630nm ± 10nm, NIR: 830nm ± 10nm). The device works through a non-thermal mechanism called photobiomodulation. The LEDs produce light at an intensity of 30mW/cm² delivering 18J/cm² per treatment.

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The power supply is used to charge the lithium polymer battery in the décoLITE controller

Substantial Equivalence Discussion

Description	Subject device (K242382)décoLITE (TN2037)	K191629faceLITE LED mask	Comparison
DeviceManufacturer	ISMART DEVELOPMENTSLTD	iSMART Marketing SVCSLtd	N/A
Device Trade Name	décoLITE	faceLITE™	N/A
DeviceClassificationname	Light Based Over theCounter WrinkleReduction	Light Based Over theCounter WrinkleReduction	Same
Device ProductCode	OHS	OHS	Same
Regulation	878.4810Laser surgical instrumentfor use in general andplastic surgery and indermatology.	878.4810Laser surgical instrumentfor use in general andplastic surgery and indermatology.	Same
DeviceClassification	Class II	Class II	Same
Rx/OTC	Over the Counter	Over the Counter	Same
Intended Use andIndications for Use	The décoLITE LED deviceis an over-the-counterdevice that is intended forthe use in the treatment ofwrinkles in the decolletagearea.	The faceLITE LED mask isan over-the-counterdevice that is intended forthe use in the treatment offull-face wrinkles.	Similar,differentanatomicallocation.
Description	Subject device (K242382)décoLITE (TN2037)	K191629faceLITE LED mask	Comparison
Intended Locationof Use	Decolletage (upper chest)	Face	Different
Energy source	Light emitting diodes	Light emitting diodes	Same
Peak Wavelength(FWHM)	Red: 630nm ± 10nmNIR: 830nm ± 10nm	Red: 630nm ± 10nmNIR: 830nm ± 10nm	Same
Intensity	30mW/cm² total	30mW/cm² total	Same
Treatment time	600 seconds (10 minutes)	600 seconds (10 minutes)	Same
Treatment protocol	5× weekly, 6 weeks	5× weekly, 6 weeks	Same
Cumulative dose	540J/cm²	540J/cm²	Same
Timers	Devices uses a timer andsoftware to controltreatment duration.	Devices uses a timer andsoftware to controltreatment duration.	Same
SoftwareControlled	Yes	Yes	Same

The décoLITE LED Device is substantially equivalent to the faceLITE LED mask (K191629).

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The Subject device has been subjected to clinical performance testing to assess the safety and effectiveness of the device in treating wrinkles of the decolletage area as described below.

Electrical Safety Testing

décoLITE was designed to meet applicable industry standards for electromagnetic compatibility (EMC) and electrical safety.

The device relies on standards identified for Medical Electrical Equipment which ensure that the product is safe and effective for its intended use regarding EMC and electrical safety.

décoLITE has been tested and found to comply with the following applicable standards:

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1. IEC 60601-1:2005/(R)2012 & A1:2012, [Incl. AMD2:2020]. Medical electrical equipment. General requirements for basic safety and essential performance
1. IEC 60601-1-2:2014 + IEC 60601-1-2:2017. Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests for: Home Healthcare Environment
1. IEC 60601-1-11:2015 + IEC 60601-1-11:2015/A1:2021 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
1. IEC 60601-2-57:2011. Medical electrical equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
1. IEC 60601-2-83:2019. Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
1. IEC 62133-2:2017. Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes – Safety Requirements for Portable Sealed Secondary Cells, and for Batteries Made from Them, for Use in Portable Applications- Part 2: Lithium systems.

Non-Clinical Performance Testing

Eye Safety

décoLITE has been tested to and complies with IEC 62471:2006, Photobiological safety of lamps and lamp systems.

Thermal safety

During normal operation with a treatment time of 10 minutes the change in skin temperature from baseline to the end of treatment is +1°C for décoLITE, with a mean skin temperature of 35.5°C at the end of normal treatment. The panel surface, when in contact with the skin, increases from baseline by +1.1℃, with a mean surface temperature of 34.6℃ at the end of normal treatment.

Light characteristics.

Test results verified the output characteristics of the devices.

Usability/Human factors

The décoLITE labeling was subject to label comprehension testing (IEC 62366-1:2015+A1:2020, Application of usability engineering to medical devices)

Seventeen subjects took part in the study, 5 male and 12 female. Eight subjects were Caucasian, 4 were Asian, and 5 were Hispanic. Six subjects identified English as a second language The mean age of the study group was 43 years of age, with a range of 24 to 58 years old. The average REALM (Rapid Estimate of Adult Literacy in Medicine) words incorrect was 7.3, with an average REALM

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score of 58.7, which represented 70-8" grade. Two subjects presented with a REALM score of 40-60 grade, 10 with a 7th-8th grade score and the remaining 5 had a score of high school.

All seventeen subjects were able to complete all tasks by following the device's labelling, including instructions for use. Per the definitions of IEC 62366-1:2015+A1:2020, all tasks were performed within correct or normal use by all subjects.

Observations of tasks that were not completed exactly as specified in the labelling were within the bounds of normal use and did not pose additional hazards.

Clinical Performance Testing

A clinical study was conducted to support the safety and effectiveness of the décoLITE LED device in treating wrinkles of the chest.

The objective of the study was to assess the safety and effectiveness of the décoLITE LED device in reducing wrinkling of the décolletage (upper chest). The treatment course for the study was 5 treatment sessions per week (on separate days), 10 minutes each, for 6 weeks. After the initial visit, treatment sessions were conducted by the subject at home, The primary effectiveness endpoint of the study was a reduction in décolleté lines after a completing a course of light therapy, measured using the validated scale developed by Landau et al. (2016).1

Twenty-five (n=25) subjects were enrolled in the study. Six subjects withdrew from the study; three of these subjects were lost to follow-up, two were unable to continue treatments for personal reasons unrelated to the study, and one was unwilling to return to the clinic for images. Nineteen subjects completed the full study treatment course. After identifying unprotected sun exposure in one of these 19 subjects, their results were excluded.

The average age of the group was 54 (range 38 to 65), and the group comprised entirely of females. Fitzpatrick skin types II, III, IV, and V were included. Of the 25 subjects, 22 identified as White/Caucasian, 2 identified as Hispanic or Latino, and 1 identified as Asian. No adverse events were reported. The mean baseline wrinkle severity was 2.5 and the mean improvement after treatment was 0.9 points. Sixteen of 19 subjects (84%) felt their wrinkles had improved and 16 of 19 subjects (84%) felt the overall appearance of their chest had improved. 16 of 19 subjects (84%) felt the overall appearance of their chest had improved.

Conclusions

iSMART Developments LTD has demonstrated that the décoLITE LED Device has an equivalent Intended Use, classification, and technological characteristics as the predicate device and is used with the same treatment regimen. The decoLITE LED is intended for use on a different body area. Clinical performance testing demonstrated improvement and no safety concerns. Therefore, the décoLITE LED Device is substantially equivalent to the referenced predicate faceLITE LED mask (K191629).

1 Landau, M., et al. (2016, July). Validated Assessment Scales for Décolleté Wrinkling and Pigmentation. Dermatologic Surgery, 42(7), 842-852.

Regulation Number and Section

§ 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.