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510(k) Data Aggregation
K Number
K241057Device Name
Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)
Manufacturer
Wuhan Guangdun Technology Co.,Ltd.
Date Cleared
2025-01-24
(281 days)
Product Code
NHN
Regulation Number
890.5500Why did this record match?
Product Code :
NHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GD-P-E Enhanced Handheld Pain Relief Laser Instrument generally indicated:
- adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin;
- adjunctive use in providing temporary relief of minor chronic pain associated with Carpal Tunnel Syndrome (CTS)
Device Description
The GD-P-E Enhanced Handheld Pain Relief Laser Instrument consists of a LCD, button, battery, power charger jack. Accessories include a power cords, a power adapter. It is a handheld, non-invasive, non-heating infrared cold laser instrument designed to be used as an adjunct treatment for managing the temporary relief of pain associated with Carpal Tunnel Syndrome. A key feature of the device is its ability to produce multiple laser wavelengths (808nm and 650nm).
A key feature of the device is its ability to emit dual laser wavelengths (808nm and 650nm), providing targeted low-level light therapy to the affected area. This "cold" laser therapy enables body tissue to absorb the light, facilitating a temporary reaction within the cells that promotes minor pain relief.
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K Number
K232813Device Name
Therapy EC, Therapy XT
Manufacturer
DMC Importacao e Exportacao de Equipamentos LTDA
Date Cleared
2024-12-19
(463 days)
Product Code
NHN
Regulation Number
890.5500Why did this record match?
Product Code :
NHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Therapy EC and Therapy XT are non-heating infrared lamps and are indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
Device Description
Therapy EC and Therapy XT are made up of ergonomic equipment that is easy to use and operate. They have one infrared laser diode (808nm). 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. Therapy EC and Therapy XT are designed to emit infrared laser light. Additionally, they are intended to be used by health care professionals such as physicians, nurses, and physical therapists, for adjunctive use in the temporary relief of hand of wrist pain associated with Carpal Tunnel Syndrome. Therapy EC and Therapy XT are consisted of components including handpiece holder, battery charging cable, battery, spacer (3 units), safety glasses, eye protector, and transportation case. The only part that touches the patient is the spacer. This component is made of polycarbonate and has the function of creating a safe distance between the Therapy tip and the patient's skin.
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K Number
K231409Device Name
Erchonia FX-405
Manufacturer
Erchonia Corporation
Date Cleared
2023-08-11
(88 days)
Product Code
NHN
Regulation Number
890.5500Why did this record match?
Product Code :
NHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Erchonia® FX-405 laser is generally indicated:
a. while using the red and violet diodes, for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.
b. and while using the red diodes, as an adjunctive treatment of postoperative pain.
Device Description
Erchonia® FX-405 is low level laser system that uses three semi-conductor diodes (visible light) 630nm to 650nm with a mean power output of 17.25mW per diode and one semi-conductor diode 400nm to 410nm with a mean power output of 23.00mW. The Erchonia®FX-405 is a variable hertz device. The variable hertz feature of the Erchonia® FX-405 is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX-405 has been classified by the FDA/EC as a Class II device and a Class 2 Laser. The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord, equipped with a medical grade transformer. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the end user to alter the laser diode output. The device has an adjustable main arm that is attached to the mobile baser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is attached to the adjustable main arm that is manually raised and lowered utilizes internal mechanics that collects the light emitted from each of the four (4) laser diodes and processes each through a proprietary patented lens which redirects the beam with a line refracted light is then bent into a spiraling circle pattern that is totally random and independent of the other diodes. This assembly can be rotated 120 degrees for proper positioning to patient for accurate treatment. The laser head assembly includes arms and pivots that allow the four (4) laser output heads to be rotated, titled, and raised / lowered independently. The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended. The exterior materials consist of 6061 T6 AL, Kydex 430 and Copolymer Acetal with powder coating and carbon fiber finish.
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K Number
K212189Device Name
FibroLux
Manufacturer
Multi Radiance Medical
Date Cleared
2022-09-02
(416 days)
Product Code
NHN
Regulation Number
890.5500Why did this record match?
Product Code :
NHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FibroLux is indicated for adjunctive use in the temporary relief of pain associated with fibromyalgia.
Device Description
Not Found
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K Number
K221987Device Name
Erchonia GVL
Manufacturer
Erchonia Corporation
Date Cleared
2022-09-01
(57 days)
Product Code
NHN, GEX
Regulation Number
890.5500Why did this record match?
Product Code :
NHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Erchonia® GVL laser is generally indicated:
a. while using the green and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,
b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
Device Description
The Erchonia® GVL (Model# GVL) is a low-level laser system that uses two semi-conductor diodes (visible green and violet light), green: 520 nm and violet: 405 nm ± 10. The Erchonia® GVL (Model# GVL) is a variable hertz device. The variable hertz feature of the Erchonia® GVL (Model# GVL) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® GVL (Model# GVL) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser.
The components of the device consist of:
An ultra-slim hand-held battery-operated control device with a docking station providing two laser diodes a 520 nanometer and a 405 nanometer. Each laser diode emits its wavelength with a tolerance of ±10 nanometer. The lasers are powered by an internal battery that is recharged using a separate inductive charging base powered by an external class II medical power supply. This configuration offers portability as well as consistency of power.
The internal battery powers the two specially created and patented electronic diodes with an output of 7.5mW ± 1mW green and <5mW violet non-convergent beam and is classified as a Class 2 laser in accordance IEC 60825-1 (Complies with 21CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50). The separate inductive charging base runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power.
A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The Erchonia® GVL (Model# GVL) as designed contains user protocols. The user protocols are defined and saved by the user in one of ten memory locations and can be changed at any time. User instructions are provided in the Erchonia® GVL Operation & Maintenance Manual for proper touchscreen interface operation for the user to set laser diode variable hertz and length of treatment time. There is no interface that allows the end user the laser power output (milliwatts) or the laser wavelength (nanometers).
The Acne protocol is factory set and cannot be altered by the end user.
The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons, work in conjunction with the component platform to ensure the device operates as intended.
The associated accessories include:
- Charging Base .
- Power Supply
- . Patient protective eyewear
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K Number
K203337Device Name
PainTB, PainTJ
Manufacturer
Ptech Co., Ltd.
Date Cleared
2022-02-11
(456 days)
Product Code
NHN
Regulation Number
890.5500Why did this record match?
Product Code :
NHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pain TB and Pain TJ Laser systems are indicated for adjunctive use in the temporary relief of low-back pain and wrist pain associated with Carpal Tunnel Syndrome.
Device Description
PainTB and PainTJ can be used repeatedly and uses semiconductor lasers to generate three wavelengths of light at 670nm, 830nm and 910nm. In general, this device irradiates to the pain area with a laser beam to relieve pain. It can also be controlled via a dedicated app on your smartphone, allowing you to monitor when and how much you have used it.
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K Number
K212595Device Name
Erchonia FX-405
Manufacturer
Erchonia Corporation
Date Cleared
2021-11-12
(88 days)
Product Code
NHN
Regulation Number
890.5500Why did this record match?
Product Code :
NHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Erchonia® FX-405 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.
Device Description
The Erchonia® FX-405 (Model#: MLS-AC) is low level laser system that uses three semi-conductor diodes (visible light) 630nm to 650nm with a mean power output of 17.25mW per diode and one semi-conductor diode 395nm to 415nm with a mean power output of 23.00mW. The Erchonia® FX-405 (Model#: MLS-AC) is a variable hertz device. The variable hertz feature of the Erchonia® FX-405 (Model#: MLS-AC) is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX-405 (Model#: MLS-AC) has been classified by the FDA/EC as a Class II device and a Class 2 Laser.
The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord, equipped with a medical grade transformer. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes can only be on or off; there is no user interface that allows the end user to alter the laserdiode output. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is attached to the adjustable main arm that is manually raised and lowered utilizes internal mechanics that collects the light emitted from each of the four (4) laser diodes and processes each through a proprietary patented lens which redirects the beam with a line refracted light is then bent into a spiraling circle pattern that is totally random and independent of the other diodes. This assembly can be rotated 120 degrees for proper positioning to patient for accurate treatment. The laser head assembly includes arms and pivots that allow the four (4) laser output heads to be rotated, tilted, and raised / lowered independently. The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended. The exterior materials consist of 6061 T6 AL, Kydex 430 and Copolymer Acetal with powder coating and carbon fiber finish. The associated accessories include: (1) Hospital grade power cord, (1) Patient protective eyewear (sufficiently and effectively block the laser light spectrum at OD 2+ @ 635nm, OD 0.75 @ 405nm VLT60), (2) Power safety lockout keys.
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K Number
K211186Device Name
Erchonia XLR8
Manufacturer
Erchonia Corporation
Date Cleared
2021-10-22
(185 days)
Product Code
NHN
Regulation Number
890.5500Why did this record match?
Product Code :
NHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Erchonia® XLR8 is generally indicated:
a. as adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin
b. as an adjunct to liposuction procedures of the thighs, hips and stomach for reduction of pain associated with the recovery process
c. for the temporary reduction in post-surgery pain at 24 hours after surgery following bilateral breast augmentation surgery
d. as an adjunctive treatment of postoperative pain
Device Description
The Erchonia® XLR8 (Model# HLS) is a low-level laser system that uses two semi-conductor diodes (visible red light), red: 640nm ±10. The Erchonia® XLR8 (Model# HLS) is a variable hertz device. The variable hertz feature of the Erchonia® XLR8 (Model# HLS) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® XLR8 (Model# HLS) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser. The Erchonia® Laser is applied externally and has proven through clinical trials to treat post-surgical pain associated with liposuction and breast augmentation surgery. The Erchonia ® XLR8 laser emits a 640-nanometer wavelength with a tolerance of ±10 nanometer, from each of the two laser are powered by an internal battery that is recharged using a separate inductive charging base powered by an external class II medical power supply. This configuration offers portability as well as consistency of power. The internal battery powers the two specially created and patented electronic diodes with an output of <10mW red laser beam.
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K Number
K191257Device Name
Erchonia EVRL
Manufacturer
Erchonia Corporation
Date Cleared
2019-08-08
(90 days)
Product Code
NHN, GEX
Regulation Number
890.5500Why did this record match?
Product Code :
NHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
a. while using the red and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,
b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
Device Description
The Erchonia® EVRL (Model# EVRL) is a low-level laser system that uses two semi-conductor diodes (visible red and violet light), red: 630-650 nm and violet: 380-450 nm. The Erchonia® EVRL (Model# EVRL) is a variable hertz device. The variable hertz feature of the Erchonia® EVRL (Model# EVRL) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® EVRL (Model# EVRL) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser.
The Erchonia® EVRL (Model# EVRL) is indicated for use:
a. while using the red and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,
b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
The Erchonia® Laser is applied externally and has proven through clinical trials to treat neck and shoulder pain with the red diode.
The components of the device consist of:
An ultra-slim hand-held battery-operated control device with a docking station providing two laser diodes a 640 nanometer and a 405 nanometer. Each laser diode emits its wavelength with a tolerance of ±10 nanometer. The lasers are powered by an internal battery that is recharged using a separate inductive charging base powered by an external class II medical power supply. This configuration offers portability as well as consistency of power.
The internal battery powers the two specially created and patented electronic diodes with an output of 7.5mW ± 1mW red and <5mW violet non-convergent beam and is classified as a Class 2 laser in accordance IEC 60825-1 (Complies with 21CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50).
The separate inductive charging base runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power.
A touch screen that functions as a display screen and inout panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off, there is no user interface that allows the end user to alter the laser diode output. The Erchonia® EVRL (Model# EVRL) as designed contains user protocols. The user protocols are defined and saved by the user in one of ten memory locations and can be changed at any time. The protocols consist of activating the lasers to emit predefined frequencies for a predetermined length of time.
The Acne protocol is factory set and cannot be altered by the end user.
The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons, work in conjunction with the component platform to ensure the device operates as intended.
The associated accessories include:
- Charging Base
- Power Supply
- Patient protective eyewear .
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K Number
K190572Device Name
Erchonia FX-635
Manufacturer
Erchonia Corporation
Date Cleared
2019-06-01
(87 days)
Product Code
NHN
Regulation Number
890.5500Why did this record match?
Product Code :
NHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Erchonia® FX-635 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.
Device Description
The Erchonia® FX-635 (Model#: HPS) is low level laser system that uses three semi-conductor diodes (visible red-light) 630nm to 650mm. The Erchonia® FX-635 (Model#: HPS) is a variable hertz device. The variable hertz feature of the Erchonia® FX-635 (Model#: HPS) is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX 635 (Model#: HPS) has been classified by the FDA/EC as a Class II/Ila device and a Class II/2 Laser.
The Erchonia® FX 635, model: HPS laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain. The Erchonia® Laser is applied externally and has proven through clinical trials to treat the neck, shoulder, low back and plantar fasciitis.
The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord, equipped with a medical grade transformer. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the end user to alter the laser diode output. The low back protocol and heel pain protocol is factory set and cannot be altered by the end user. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is attached to the adjustable main arm that is manually raised and lowered, utilizes internal mechanics that collects the light emitted from each of the three (3) laser diodes that rotate in a spiraling circle pattern that is totally random and independent of the other diodes. The laser head assembly is positioned 3-4 inches from the patient's skin to deliver treatment for pain. This assembly can be rotated 120 degrees for proper positioning to patient for accurate treatment. The laser head assembly includes arms and pivots that allow the three (3) laser output heads to be rotated, tilted, and raised / lowered independently. The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended.
The associated accessories include:
- Hospital grade power cord
- Patient protective eyewear
- Power safety lockout keys
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