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510(k) Data Aggregation
K Number
K250224Device Name
handLITE (TN19S)
Manufacturer
iSMART Developments LTD
Date Cleared
2025-04-18
(81 days)
Product Code
ONE
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
iSMART Developments LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The handLITE is intended to emit energy in the red and near infrared region of the light spectrum, is generally indicated to treat dermatological conditions and specifically indicated to treat contact dermatitis of the hand and wrist.
Device Description
The handLITE device consists of:
1. Flexible silicone glove with integrated controller (contains rechargeable lithium-ion polymer battery)
2. Power supply and country specific adaptors
handLITE is a home use wearable light emitting diode (LED) phototherapy device.
The device consists of a flexible silicone glove that contains red (630nm) and near infrared (830nm) light emitting diodes (LEDs) and an integrated controller. The LEDs generate the light at an intensity of 30mW/cm², delivering 18J/cm² per treatment.
The power supply is used to charge the integrated Lithium battery in the handLITE.
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K Number
K242382Device Name
décoLITE LED Device
Manufacturer
ISMART Developments Ltd
Date Cleared
2024-11-08
(88 days)
Product Code
OHS
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ISMART Developments Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The décoLITE LED device is an over-the-counter device that is intended for the use in the treatment of wrinkles in the decolletage area.
Device Description
The décoLITE device consists of:
- 1. Flexible silicone panel
- 2. Controller
- 3. Power supply and country specific adaptors
- 4. 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
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K Number
K231555Device Name
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
Manufacturer
iSMART Developments Ltd
Date Cleared
2023-07-27
(58 days)
Product Code
OHS, OLP
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
iSMART Developments Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LUMA LED light patches are over-the-counter devices intended to emit energy in the visible and near infra-red light spectrum.
LUMA Blemish is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face.
LUMA Revive is an over-the-counter device intended to emit energy in the red and Near infra-red spectrum and is intended for the use in the treatment of facial wrinkles.
Device Description
The LUMA Patches (Blemish and Revive) are battery operated, cordless wearable Light emitting diode (LED) devices intended to emit an even, cool, narrow band of light in the blue (415nm), red (630nm) and near infra-red (830nm) spectrum for the treatment of mild to moderate acne vulgaris and facial wrinkles. The devices work through non-thermal mechanisms called photobiomodulation (wrinkles) and endogenous Photodynamic therapy (acne vulgaris).
LUMA Blemish and LUMA Revive consists of the following key components.
- 1. Silicone flexible patches
- 2. Adhesive hydrocolloid patches x14
- 3. Magnetic 2 pin, 4mm to USB A connector
- User manual 4.
The LUMA patches are home use wearable LED phototherapy devices composed of flexible patches containing Light emitting diodes (LEDs). The LEDs generate the light.
The LUMA patches are comprised of an endo skeleton made of silicone containing an upper surface made of Polyurethane (PU) that houses the ON/OFF button magnetic charging pins and a battery charging indicator and a lower surface manufactured from Polyethylene terephthalate (PET).
The LEDs produce blue, red and near infra-red (NIR) light in the visible spectrum.
LUMA Blemish (Blue: 415nm +/- 10nm and Red: 630nm +/- 10nm)
LUMA Revive (Red: 630nm +/- 10nm and NIR 830nm +/-10nm.).
The LEDs are driven by an integrated 3.7V, 37mAh Lithium Polymer battery.
The battery is charged via a magnetic 2 pin, 4mm to USB A connector that plugs into a standard 5v USB A power adaptor. The device cannot be operated while in charging mode. The device contains a charging watchdog that prevents overcharge. The battery status of the devices is relayed to the user by a single indicator LED on the upper surface of the LUMA patches (during charging) and by the treatment LEDs on the lower or inner surface (during treatment).
The LUMA patches contain a simple ON/OFF button on the upper surface of the patch that switches the LEDs ON. The treatment time is 10 minutes. The devices automatically turn OFF after 600 seconds (10 minutes). The user may stop the treatment program during the 10 minutes by pressing the ON/OFF button.
The LUMA patches are worn on the face and are held in place by an adhesive hydrocolloid patch.
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