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Found 406 results
510(k) Data Aggregation
(85 days)
Re: K253349**
Trade/Device Name: Hair Regrowth Cap (Model: T-119-HRC)
Regulation Number: 21 CFR 890.5500
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| Common Name | Infrared lamp |
| Classification Name | Laser, Comb, Hair |
| Regulation Number | 890.5500
Hair Regrowth Cap is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
The Hair Regrowth Cap (HRC) is a wearable device designed to treat androgenetic alopecia in both men and women. The cap utilizes LED light phototherapy to stimulate hair regrowth through a daily treatment session of approximately 10 minutes.
The system consists of a soft, comfortable textile cap embedded with LEDs, powered by a rechargeable battery. It includes driver electronics and is easily operated via a built-in switch button located on the cap. Hair Regrowth Cap device cannot operate while charging. The device has no communication function.
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(88 days)
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| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810, 21 CFR 890.5500 | 21 CFR 878.4810 |
21 CFR 878.4810 | 21 CFR 878.4810 21 CFR 890.5500 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Classification
The device is an over the counter device that is intended for:
- Red+Infrared light: Treatment of full-face wrinkles;
- Red+Blue+Infrared light: Treatment of mild to moderate inflammatory acne;
- Yellow+Infrared light: Treatment of full-face wrinkles.
The LED Light Therapy Mask (Models: M19, M19-1, M19-2, M19-3, M19-5, M19-6) is an Over-the-Counter (OTC), home-use, wearable LED phototherapy device, and intended for the use of treating full-face wrinkles and mild to moderate acne. Light radiates from the inner surface of the device onto the face. This light is generated by LED with four different spectrum wavelengths: red (660nm), infrared (850nm), yellow (590nm) and blue (460nm). The LED Light Therapy Mask is consisting of main unit (mask), controller and USB charging cable. The device is powered by rechargeable Li-battery and controlled by a controller that is connected to the main unit. The device's power-on/off, mode switch, intensity adjustment and time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over.
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(87 days)
Plastic Surgery, Physical Medicine
Product Code: OHS, OLP, ILY
Regulation Number: 878.4810, 890.5500
KFB265, KFB293) | N/A |
| 510 (K) Number | K253086 | K241857 | N/A |
| Regulation number | 878.4810, 890.5500
| 878.4810, 890.5500 | N/A |
| Classification Panel | General & Plastic Surgery, Physical Medicine |
The Led Light Therapy Device (Model: SG-FM) is an Over-the-Counter medical device intended for treatment of wrinkles and mild to moderate inflammatory acne.
- Red light: Treatment of wrinkles.
- Red+Infrared Light: Treatment of wrinkles.
- Amber light: Treatment of wrinkles.
- Blue Light: Treatment of mild to moderate inflammatory acne.
The Led Light Therapy Device (Model: SG-FE) is an Over-the-Counter medical device intended for treatment of wrinkles.
- Red light: Treatment of wrinkles.
- Red+Infrared light: Treatment of wrinkles.
- Infrared light: Provide topical heating for the purpose of elevating tissue temperature, and to temporarily increase local blood circulation.
The Led Light Therapy Device is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne. LED Light Therapy Device is consisting of LED mask, controller, silicone eye protector, USB charging cable and straps.
The LED Light Therapy Device (Model:SG-FM) have 4 types of light, which include Red light (wavelength 630nm), Blue light (wavelength 460nm), Infrared light (wavelength 850nm), and Amber light (wavelength 605nm).
The LED Light Therapy Device (Model:SG-FE) have 2 types of light, which include Red light (wavelength 630nm) and Infrared light (wavelength 850nm).
The LED Light Therapy Device is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.
The device operates on an internal lithium rechargeable battery. The rechargeable battery can be charged from the external charging adapter through the provided USB Charging Cable.
The USB charging cable is only used for charging, and the device cannot be used while charging.
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(143 days)
SP 14026-563
Brazil
Re: K252273
Trade/Device Name: Therapy US
Regulation Number: 21 CFR 890.5500
For Adjunctive Use In Pain Therapy
Product Code
NHN
Classification Regulation
21 CFR 890.5500
| Design | | | Equivalent |
| Product code | NHN | NHN | Equivalent |
| Regulation number | 21 CFR 890.5500
| 21 CFR 890.5500 | Equivalent |
| Class | Class II | Class II | Equivalent |
| Indications for use
Regulatory Classification**
Both devices share the product code NHN and are regulated under 21 CFR 890.5500
Therapy US is generally indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
The Therapy US consists of an ergonomic device that is easy to use and operate. The device has a red laser diode (660 nm) and an infrared laser diode (808 nm). Two optical fibers conduct the laser light emitted by each emitter. The optical power emitted is controlled by the electrical current in the laser diodes.
The Therapy US should be used by doctors, nurses, and physical therapists for adjunctive use in temporary pain relief of minor chronic neck and shoulder pain in patients.
The Therapy US consists of components including a handpiece, handpiece holder, battery charging cable, spacer (3 units), safety glasses, eye protection, and carrying case. The only part that comes into contact with the patient is the spacer. This component is made of polycarbonate, and its function is to create a safe distance between the tip of the therapy device and the patient's skin.
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(90 days)
Fat Reducing Low Level Laser |
| Regulation Number | 878.5400 |
| Product Code(s) | OLI, ILY, 21 CFR 890.5500
Led Light Phototherapy Bed is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
Led Light Phototherapy Bed is indicated to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, and pain and stiffness associated with arthritis, for promoting relaxation of the muscle tissue, and to temporarily increase local blood circulation.
LED phototherapy bed is a low-intensity LED light source (red and infrared LED) system that uses 630nm light to reduce the circumference of the hips, waist, and thighs for aesthetic benefits, and temporarily increases skin temperature using 630nm, 660nm, 855nm, and 940nm light.
The device consists of two LED panels, a software control console for selecting and maintaining LED light applications, a power adapter, and cables connected to the energy source. The LED panels can be adjusted to roughly fit the external dimensions of the patient being treated. The device is powered by connecting it to an 220-240V AC, at4000VA, 50-60Hz power source.
The equipment is controlled by professional operators. The operator control device includes additional safety measures, including an emergency stop button. If activated, the emergency stop will stop the program and shut down, delivering power to the treated person through the LED light.
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(57 days)
Plastic Surgery, Physical Medicine
Product Code: OHS, ILY
Regulation Number: 878.4810, 890.5500
| 510 (K) Number | K253073 | K241857 | K242382 | K223544 |
| Regulation number | 878.4810, 890.5500
| 878.4810, 890.5500 | 878.4810 | 878.4810, 890.5500 |
| Classification Panel | General & Plastic
The Led Light Therapy Device (Model:SG-FSM) is an Over-the-Counter medical device intended for treatment of wrinkles in the face and decolletage area.
- Red light: Treatment of wrinkles.
- Red+Infrared Light: Treatment of wrinkles.
- Amber light: Treatment of wrinkles.
- Amber+Infrared Light: Treatment of wrinkles.
The Led Light Therapy Device (Model:SG-NK) is an Over-the-Counter medical device intended for treatment of wrinkles in the decolletage area.
- Red light: Treatment of wrinkles.
- Red+Infrared Light: Treatment of wrinkles.
- Amber light: Treatment of wrinkles.
- Amber+Infrared Light: Treatment of wrinkles.
The Led Light Therapy Device (Model:SG-CT) is an Over-the-Counter medical device intended for treatment of wrinkles in the decolletage area.
- Red light: Treatment of wrinkles.
- Red+Infrared light: Treatment of wrinkles.
- Infrared light: Provide topical heating for the purpose of elevating tissue temperature, and to temporarily increase local blood circulation.
The Led Light Therapy Device is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles.
LED Light Therapy Device(Model:SG-FSM) is consisting of Flexible silicone panel (LED mask and upper chest), controller, silicone eye protector, USB charging cable and straps.
LED Light Therapy Device(Model:SG-NK, SG-CT) is consisting of Flexible silicone panel (upper chest), controller, USB charging cable and straps.
The LED Light Therapy Device(Model:SG-FSM) have 3 types of light, which include Red light (wavelength 630nm), Infrared light (wavelength 850nm for LED mask, wavelength 830nm for upper chest) and Amber light (wavelength 605nm).
The LED Light Therapy Device(model:SG-NK) have 3 types of light, which include Red light (wavelength 630nm), Infrared light (wavelength 830nm) and Amber light (wavelength 605nm).
The LED Light Therapy Device (Model:SG-CT) have 2 types of light, which include Red light (wavelength 630nm) and Infrared light (wavelength 830nm).
The LED Light Therapy Device is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.
The device operates on an internal lithium rechargeable battery. The rechargeable battery can be charged from the external charging adapter through the provided USB Charging Cable. The USB charging cable is only used for charging, and the device cannot be used while charging.
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(90 days)
K252414**
Trade/Device Name: Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
Regulation Number: 21 CFR 890.5500
Review Panel: General & Plastic Surgery
Product Code: OAP
Regulation Number: 21 CFR 890.5500
Review Panel: General & Plastic Surgery
Product Code: OAP
Regulation Number: 21 CFR 890.5500
Review Panel: General & Plastic Surgery
Product Code: OAP
Regulation Number: 21 CFR 890.5500
| 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 | Same |
| Indications for Use
The Q-Renew LLLT Hair Growth Helmet is indicated for the promotion of hair growth in males who have Norwood-Hamilton classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.
The Q-Renew LLLT Hair Growth Helmet is a non-invasive, at-home low-level laser/light therapy (LLLT) device designed to promote hair growth in both men and women. It uses a dual light system that combines laser diodes (wavelength 655nm) with LEDs (wavelengths 630nm, 660nm, and 680nm) to deliver optimal light absorption by the scalp.
The device consists of a Q-Renew LLLT helmet, a charging base and a USB-C charging cable.
The helmet features an adjustable fit, controlled by a rear adjustment wheel, and an intuitive LCD screen for operation. Users can:
- Start or pause treatments
- Select treatment zones
- Check battery status
- View remaining session time
The helmet has a power button for turning the device on/off. The device also includes smart sensors—removing the helmet automatically pauses the session, while repositioning it resumes treatment. Each session lasts 12 minutes, after which the device stop the treatment automatically.
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(118 days)
Class:** II
Product Code: OHS, OLP, OAP, ISA
Regulation Number: 21 CFR 878.4810; 21CRF 890.5500
VITA Multi-Function Head Brush is an Over-The-Counter (OTC) device.
Head Mode: The device is indicated to promote hair growth in male with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic aplopecia who have Ludwig-Savin Classification of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.
Face Mode:
LED therapy function: The device is indicated for the treatment of full face wrinkles and/or mild to moderate inflammatory acne.
The VITA Multi-Function Head Brush is a hand-held device. It consists of a host, a removable treatment head, and a charging cable. The host has a button, indicator lights, and the device's power-on/off, treatment mode switch can be achieved by pressing the button. The removable treatment head has lights row, stainless steel bristles and liquid reservoir (applicable for model TB-2443F/ TB-2442AF), of which the liquid reservoir is used for the hair care after treatment.
The LEDs and low-level lasers in the removable treatment head emit light on the treatment area. In addition, the device is also equipped with a built-in micro motor to generates micro-vibration to relax the facial skin. The device has a head mode and face mode, and the device will automatically shut down after each mode completes treatment within 10 minutes. The device is powered by a built-in rechargeable lithium battery.
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(89 days)
Shanghai,
China
Re: K252325
Trade/Device Name: Hair Growth Laser Cap
Regulation Number: 21 CFR 890.5500
growth
Trade Name: Hair Growth Laser Cap
Classification Name: Infrared lamp per 21 CFR 890.5500
Plastic Surgery
Regulatory Class: II
Product Code: OAP
Regulation Number: 21 CFR 890.5500
Hair Growth Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.
Hair Growth Laser Cap is a dome-shaped low level laser therapy (LLLT) device is designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of laser diodes at 650nm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included battery pack.
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(88 days)
k) Number | K223544 |
| Product Code | OHS, OLP,ILY |
| Regulation Number | 21 CFR 878.4810, 21 CFR 890.5500
|
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810, 21 CFR 890.5500
The MEGELIN LED Light Therapy Mask is an Over-the-Counter (OTC) light based device.
- Red light: Treatment of full-face wrinkles.
- Blue light (only suitable model JML1, JML3, JML5, JML6, JML9 Face mask): Treatment of mild to moderate inflammatory acne.
The MEGELIN LED Light Therapy Mask uses blue light (460nm) to treat acne. The MEGELIN LED Light Therapy Mask uses red light (660nm) to irradiate on the facial skin that help reduce wrinkles.
JML1, JML3, JML5, JML6, JML9 are face masks, with the only difference in energy density setting, while JML2, JML4, JML7, JML8, JML10 are neck masks with the only difference in energy density setting.
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