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510(k) Data Aggregation
K Number
K250761Device Name
KALA Therapy Wand (Model: KALA-03)
Manufacturer
SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD
Date Cleared
2025-07-11
(120 days)
Product Code
OHS, ISA, OLP
Regulation Number
878.4810Why did this record match?
Product Code :
OHS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K250966Device Name
CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)
Manufacturer
Shenzhen Kaiyan Medical Equipment Co., Ltd
Date Cleared
2025-06-25
(86 days)
Product Code
OHS
Regulation Number
878.4810Why did this record match?
Product Code :
OHS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.
Device Description
The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is a home use wearable LED phototherapy device whose purpose is to produce an even, cool, narrow band of light for aesthetic indication for treating facial wrinkles. It emits light energy in the red and near infrared (NIR) region of the light spectrum.
The device consists of a flexible silicone mask that contains light emitting diodes (LEDs) and a controller, multi-straps, a USB-C charging cord, a pair of eye inserts and a storage bag. The LEDs generate the light. The mask is worn on the face and is held in place by the adjustable strap. The controller contains a rechargeable Lithium ion polymer battery and controls power to the mask. The controller has only one key to switch the LEDs ON/OFF and it will automatically shut down after a 10-minute treatment is completed.
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K Number
K243978Device Name
LED Facial Mask
Manufacturer
Shenzhen Sunsred Technology Co.,Ltd
Date Cleared
2025-06-20
(179 days)
Product Code
OHS, ILY, OLP
Regulation Number
878.4810Why did this record match?
Product Code :
OHS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LED Facial Mask is an over-the-counter (OTC) device intended for the following uses:
For Red Mode(s): The device emits energy in the red spectrum and is intended for the treatment of full-face wrinkles.
For Red + NIR Mode: The device emits energy in the red and infrared spectrum and is intended for the treatment of full-face wrinkles.
For Blue Mode: The device emits light in the blue region of the spectrum and is specifically indicated for the treatment of mild to moderate acne on the face.
For NIR Mode: The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Device Description
The LED Facial Mask is a device used for treatment of full-face wrinkles, mild to moderate acne on the face, and providing topical heating. LEDs housed inside the device emit light onto the face. These LEDs generate blue, red, and infrared wavelengths.
This product is composed of the main device, controller, fastening straps, storage bag, blindfold, and charging cable.
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K Number
K250880Device Name
LED LIGHT MASK (A093)
Manufacturer
Foshan Guangyu Weilai Medical Equipment Co., Ltd.
Date Cleared
2025-06-20
(88 days)
Product Code
OHS
Regulation Number
878.4810Why did this record match?
Product Code :
OHS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Red light: Treatment of full-face wrinkles.
- Blue light: Treatment of mild to moderate inflammatory acne.
- Red+Blue light: Treatment of mild to moderate inflammatory acne.
The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Device Description
The LED LIGHT MASK adopts light emitting diodes (LED) in the red (635nm ± 5nm) + blue (425 ± 5nm) and red-blue (635nm + 425nm ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect (i.e. treatment of wrinkles and mild to moderate acne. The LED LIGHT MASK adopts the form of a mask that contains 64 LEDs on the inner surface of the main unit. A wired controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). The subject device operates in three treatment modes. One mode emits red light, one mode emits blue light, and the third mode emits red-blue light (i.e. mixed light). To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, the user must wear the product before turning it on, then the built-in eye mask of the face mask can block the radiation of LED light to the eyes during each treatment.
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K Number
K250830Device Name
LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
Manufacturer
Shenzhen Sungrow LED Technology Co., Ltd.
Date Cleared
2025-06-09
(82 days)
Product Code
OHS
Regulation Number
878.4810Why did this record match?
Product Code :
OHS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Red light: Treatment of full-face wrinkles.
- Yellow light: Treatment of full-face wrinkles.
- Red+Infrared light: Treatment of full-face wrinkles.
- Blue light: Treatment of mild to moderate inflammatory acne.
- Mixed light (Red+Blue+Infrared): Treatment of mild to moderate inflammatory acne.
Device Description
Not Found
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K Number
K251042Device Name
Light Therapy System (M500, L6)
Manufacturer
Guangzhou Ahead Intelligent Technology Co., Ltd.
Date Cleared
2025-06-06
(64 days)
Product Code
OHS, OLP
Regulation Number
878.4810Why did this record match?
Product Code :
OHS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Blue light: Treatment of mild to moderate inflammatory acne.
- Red+IR light: Treatment of facial wrinkles.
- Amber light: Treatment of facial wrinkles.
- Mixed light: Treatment of mild to moderate inflammatory acne.
Device Description
The Light Therapy System is an Over-the-Counter (OTC), home-use, wearable light based device, and intended for the use in treating full-face wrinkles and mild to moderate inflammatory acne. Light radiates from the inner surface of the device onto the face. This light is generated by LED with four different spectrum wavelengths: blue (460nm), amber (605nm), red (630nm) and infrared (850nm), and the device has four light treatment, that is, blue light and mixed light mode to treat acne, while amber light mode and red+ IR mode to treat facial wrinkles.
The device is powered by external power supply by connecting with the power adapter and controlled by the controller that should be connected to the main unit. The device's power-on/off, mode switch and treatment time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over.
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K Number
K250532Device Name
Solawave 2-in-1 Skincare Mini (Model: 61043)
Manufacturer
Shenzhen Kaiyan Medical Equipment Co., Ltd
Date Cleared
2025-05-22
(87 days)
Product Code
OHS
Regulation Number
878.4810Why did this record match?
Product Code :
OHS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Solawave 2-in-1 Skincare Mini (Model: 61043) is an over-the-counter device that emits energy in the red and infrared spectrum for treating wrinkles on the face and decolletage.
Device Description
The Solawave 2-in-1 Skincare Mini (Model: 61043) is a hand-held, battery-powered device that reduce wrinkles by emitting LED red light (630nm) and infrared light (830nm). The device is powered by a Lithium-Ion rechargeable battery, and it comes with a charging cable, storage bag, and instruction manual.
The Solawave 2-in-1 Skincare Mini is a revolutionary device that offers two simultaneous approaches for your skin routine in one handheld device:
1. Red and Near-Infrared Light Therapy
2. Warming function (This function is not for medical purpose)
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K Number
K244020Device Name
Wrinkle Treatment Device (JM1, JM2B)
Manufacturer
Shenzhen Qianyu Technology Co., Ltd.
Date Cleared
2025-05-01
(125 days)
Product Code
OHS
Regulation Number
878.4810Why did this record match?
Product Code :
OHS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wrinkle Treatment Device is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.
Device Description
The Wrinkle Treatment Device is an Over-the-Counter (OTC), home-use, wearable light based device, and intended for the use in treating full-face wrinkles. Light radiates from the inner surface of the device onto the face. This light is generated by VCSEL (Vertical-cavity surface-emitting laser) with two different spectrum wavelengths: red (660nm) and infrared (850nm).
Model JM1 is controlled directly by the button on the main mask body, which can realize device's power on/off and mode switch. The device will automatically shut down when the treatment time is over or when the pure water is run out.
Model JM2B is controlled by a controller that is connect to the main unit and the device's power-on/off, mode switch and treatment time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over. Both models are powered by rechargeable Li-battery.
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K Number
K242151Device Name
Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)
Manufacturer
Shenzhen Nuon Medical Equipment Co., Ltd
Date Cleared
2025-04-08
(259 days)
Product Code
OHS
Regulation Number
878.4810Why did this record match?
Product Code :
OHS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Radiant Renewal Skincare Wand (Models: HD-44, HD-44A, HD-44B, HD-69, HD-69A) is an over-the-counter device intended for the treatment of full-face wrinkles.
The Radiant Renewal Skincare Wand (Models: HD-44C, HD-69B) is an over-the-counter device intended for the treatment of mild to moderate inflammatory acne.
Device Description
The Radiant Renewal Skincare Wand (Models: HD-44, HD-44A, HD-44B, HD-44C, HD-69, HD-69A, HD-69B) is a handheld rechargeable device powered by a Lithium-Ion battery, designed for single-patient use. It offers wrinkle reduction through the emission of red light (wavelength: 630nm±10nm) and infrared light (wavelength: 830nm±10nm), yellow light (wavelength: 590nm±10nm), acne treatment through the emission of blue light (wavelength: 415nm±10nm).
Model HD-44 offers red and infrared light for wrinkle reduction. Models HD-44A and HD-69A only provide red light for wrinkle reduction. Models HD-44B and HD-69 use only yellow light for wrinkle reduction. And models HD-44C and HD-69B offers blue light for acne treatment. The ergonomic design of the device ensures ease of use, making them suitable for daily home skincare routines.
The package includes the main unit, a charging cable, a user manual, a tray. Each model is equipped with a single button to turn the device on or off. The device will automatically shut down after 5 minutes of operation.
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K Number
K242385Device Name
LED Therapy Mask (MN1, M226)
Manufacturer
Shenzhen Borria Technology Co., Ltd
Date Cleared
2025-04-07
(238 days)
Product Code
OHS, ILY, OLP
Regulation Number
878.4810Why did this record match?
Product Code :
OHS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Red light: Treatment of full- face wrinkles.
Blue light (only suitable model M226 and MN1 LED Facial Mask): Treatment of mild to moderate inflammatory acne.
Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Mixed light: Treatment of full face wrinkles.
Device Description
The subject device LED Therapy Mask is a home use wearable LED phototherapy device whose purpose is to produce an even and narrowband of light for the treatment of cosmetic indications including facial wrinkles and acnes.
The subject device consists of a mask body unit that contains light emitting diodes (LEDs), a controller, straps and Type-C charging cable. And the device is powered by built-in rechargeable lithium battery on the controller.
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