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Found 413 results
510(k) Data Aggregation
(98 days)
| 21 CFR 890.5500 | Identical |
| Classification | Class II | Class II | Identical |
| Indication for
| 21 CFR 890.5500 | 21 CFR 890.5500 | Identical |
| Classification | Class II | Class II | Class II
| 21 CFR 890.5500, 21 CFR 878.4810 | 21 CFR 890.5500 | Identical |
| Classification | Class II | Class
| 21 CFR 890.5500, 21 CFR 878.4810 | 21 CFR 890.5500 | Identical |
| Classification | Class II | Class
| 21 CFR 890.5500, 21 CFR 878.4810 | 21 CFR 890.5500 | Identical |
| Classification | Class II | Class
(1) The CureLight Medical Diode Laser Systems, include model: CureLight F2-A15 and CureLight F2-A30, are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.
(2) The CureLight Medical Diode Laser Systems, model: CureLight F2-B15, CureLight F2-B30, CureLight F3-AB30 and CureLight F3-AB60 are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.
The CureLight Medical Diode Laser Systems, model: CureLight F2-B15, CureLight F2-B30, CureLight F3-AB30 and CureLight F3-AB60 are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
The "CureLight Medical Diode Laser Systems", include model: CureLight F2-A15, CureLight F2-A30, CureLight F2-B15, CureLight F2-B30, CureLight F3-AB30 and CureLight F3-AB60. Which consist of three main components:
(1) Main device;
(2) Foot switch;
(3) Accessories.
Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.
The diode laser for this unit is GaAlAs diode bar, and the wavelength is 810/980nm. It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the PHOMED'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber.
MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system. It supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.
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(88 days)
SharkNinja Operating, LLC | / |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810, 21 CFR 890.5500
- 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.
LED Light Therapy Mask (Models: T2, RLD10) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne. LED Light Therapy Mask consists of main unit (mask, safety goggles), controller, Type-C charging cable and straps. There are 3 kinds of light, which include Red light (wavelength 630nm), Blue light (wavelength 470nm), Infrared light (wavelength 850nm). All models can output 3 kinds of treatment modes: red+infrared, blue and red+infrared+blue light.
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(89 days)
HP1800PRO
| Classification | |
|---|---|
| Regulation Number: | 21 CFR 878.481021 CFR 890.5500 |
The LED Therapy Light is an over-the-counter (OTC) device intended for the following uses:
For Red Mode: The device emits energy in the red spectrum and is intended for the treatment of full-face wrinkles.
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.
For Red + NIR Mode: The device emits energy in the red and infrared spectrum and is intended for the treatment of full-face wrinkles.
The LED Therapy Light employs dual-spectrum LEDs that emit red and near-infrared light, allowing simultaneous delivery of both wavelengths for synergistic treatment effects.
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(244 days)
Re: K251903
Trade/Device Name: Erchonia DPN Laser (Model# EVRL)
Regulation Number: 21 CFR 890.5500
Light-Based Laser Non-Thermal Instrument with Non-Heating Effect for Adjunctive Use in Pain Therapy (21 CFR 890.5500
The Erchonia® DPN Laser is indicated while using the red and violet diode simultaneously for prescription home use as an adjunctive treatment in providing temporary relief of diabetic peripheral neuropathy foot pain.
The Erchonia® DPN Laser (Model# EVRL) is a handheld, self-contained, lightweight, battery-operated low-level laser therapy (LLLT) device designed for use in prescription home environments. It delivers non-thermal, non-invasive laser light at specific wavelengths to provide a therapeutic benefit without generating heat. The DPN Laser builds upon the red and violet laser technology of the predicate Erchonia® EVRL (K191257), which is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin under product code NHN.
The DPN Laser device utilizes two semiconductor laser diodes that emit visible red (640 nm ± 10 nm) and violet (405 nm ± 10 nm) light, each delivering 7.5 mW.
The DPN Laser incorporates a single, non-adjustable neuropathy treatment protocol, which is pre-programmed into the device and not accessible for modification by the end user. There is no interface available that permits alteration of the laser output power or wavelength, ensuring consistent and controlled therapeutic delivery.
The laser is powered by an internal rechargeable battery. Recharging is accomplished via a separate inductive charging base, which operates using an external medical-grade power supply compatible with 120V/60Hz or 220V/50Hz AC mains power. The DPN Laser system features a user-friendly touchscreen interface that functions as both a display and control panel. The touchscreen communicates with the internal printed circuit board (PCB) to initiate or pause laser energy delivery. Detailed operating instructions for touchscreen use and treatment application are provided in the Erchonia DPN Laser Proper Use Reference guide.
The associated accessories include:
- (1) DPN Laser (no assembly required)
- (1) Proper Use Reference Guide
- (1) Laser Safety Goggles
- (1) Charger Base
- (1) Charger Base Power Supply Connector
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(424 days)
use
Classification Name: Fat Reducing Low Level Laser
Regulation Number(s): §878.5400; §890.5500
The Contour Light CL-100 device is intended for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
The Contour Light CL-100 device 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.
The Contour Research, LLC Contour Light CL-100 device applies a light emitting diode (LED) technology, and is used to perform red light LED-based circumferential reduction of the hips, thighs and waist in adults within a treatment time of 30 minutes. The device is comprised of a panel of LEDs that is adjustable to conform generally to the outer dimensions of the individual being treated, a software controlled console that is used to select and maintain the application of the LED light, a medical-grade power adaptor, and cables that connect to the energy source.
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(60 days)
For Acne(OLP), Infrared, Therapeutic Heating(ILY)
Regulation number: 21 CFR 878.4810, 21 CFR 890.5500
2 of 12**
| Product Code | OHS, OLP, ILY |
|---|---|
| Regulation Number | 21 CFR 878.4810, 21 CFR 890.5500 |
| ) Number | K241857 |
| Product Code | OHS, OLP, ILY |
| Regulation Number | 21 CFR 878.4810, 21 CFR 890.5500 |
| 21 CFR 878.4810 21 CFR 890.5500 | 21 CFR 878.4810 |
| 21 CFR 878.4810 21 CFR 890.5500 | Same |
| Regulation Name | Light Based Over The Counter Wrinkle |
*Red+Infrared light: Treatment of full-face wrinkles.
*Red light: Treatment of full-face wrinkles.
*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.
*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.
LED Light Therapy Mask (Model: RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Mask is consisting of main unit(mask), controller, Type-C charging cable and so on. There are 3 kinds of light, which include Red light (wavelength 630nm), Blue light (wavelength 465nm), Infrared light (wavelength 850nm). All models can output 5 kinds of treatment modes: red+infrared, red, infrared, blue and red+blue light.
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(63 days)
Trudermal Halo Hair Growth System (m-180a); Aduro Hair Growth (m-130,m300)
Regulation Number: 21 CFR 890.5500
General & Plastic Surgery
510(K) Number: K253669
Product Code: OAP
Regulation Number: 890.5500
Review Panel:** General & Plastic Surgery
Product Code: OAP
Page 7
Regulation Number: 890.5500
K213025
Review Panel: General & Plastic Surgery
Product Code: OAP
Regulation Number: 890.5500
The device are 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 Aduro Hair Growth (Model: M-130) is a device designed to be used with a baseball cap that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 660nm±10nm. The device is designed as a head-mounted product, and it consists of the main unit, a controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.
The Trudermal Halo Hair growth system (Model: M-180A) is a device designed to be used with a baseball cap that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 660nm±10nm. The device is designed as a head-mounted product, and it consists of the main unit, a controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.
The Aduro Hair Growth (Model: M-300) is a device designed to be used with a baseball cap that emits led light and Laser with the intention to promote hair growth. The device provides distributed led and laser to the scalp at 650nm (±10nm). The device is designed as a head-mounted product, and it consists of the main unit, a controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 25-minute treatment is completed.
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(85 days)
Re: K253349**
Trade/Device Name: Hair Regrowth Cap (Model: T-119-HRC)
Regulation Number: 21 CFR 890.5500
|
| 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)
. | / |
| 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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