(57 days)
No
The description focuses on the hardware (laser diodes, control device, touch screen) and basic software for user interface and pre-set protocols. There is no mention of algorithms that learn from data or adapt based on input, which are characteristic of AI/ML.
Yes.
The device is used to provide temporary relief of minor chronic neck and shoulder pain and to treat dermatological conditions, specifically moderate inflammatory Acne Vulgaris, which are therapeutic applications.
No
Explanation: The device is indicated for providing temporary relief of pain and treating dermatological conditions, which are therapeutic uses, not diagnostic ones. It states its intended use is to provide "temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin" and "to treat moderate inflammatory Acne Vulgaris," neither of which involve diagnosis.
No
The device description clearly outlines hardware components including laser diodes, a hand-held control device, a docking station, an internal battery, an inductive charging base, and a touch screen. While it contains software, it is integral to the operation of the physical laser system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Erchonia® GVL laser is a therapeutic device that applies light energy directly to the body for pain relief and treatment of acne. It does not analyze any samples taken from the body.
- Intended Use: The intended uses described are for treating pain and a dermatological condition, not for diagnostic testing of biological samples.
- Device Description: The description focuses on the physical components of the laser system and how it delivers light energy, not on any components for sample handling or analysis.
- Performance Studies: The performance study evaluates the device's effectiveness in reducing pain based on patient-reported outcomes (VAS scores), not on the results of laboratory tests.
Therefore, the Erchonia® GVL laser is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
NHN, GEX
Device Description
The Erchonia® GVL (Model# GVL) is identical to the predicate device, the Erchonia® EVRL cleared under K191257, including device enclosure, functionally and software. The only difference between the Erchonia® GVL and the Erchonia® EVRL is the color of laser emission (green and violet as a replacement for red and violet).
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 tolerence 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
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
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September 1, 2022
Erchonia Corporation Travis Sammons Contact Address
Re: K221987
Trade/Device Name: Erchonia® GVL Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: NHN, GEX Dated: June 30, 2022 Received: July 6, 2022
Dear Travis Sammons:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221987
Device Name Erchonia® GVL
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Residential Use (Part 21 CFR 201.326(a) Subject Clause) |
|---|
| □ Over-The-Counter Use (21 CFR 201.326(c) Subject Clause) |
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K221987
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Owner Information Name and Address of Sponsor / Manufacturer
Erchonia Corporation 650 Atlantis Rd. Melbourne, FL 32904 Telephone: 321-473-1251 Fax: 321-473-1608
Establishment Registration Number 2032513
Name and Address of Official Correspondent
Erchonia Corporation 650 Atlantis Rd. Melbourne, FL 32904 Contact: Travis Sammons Telephone: 321-473-1251 Fax: 321-473-1608 Email: tsammons@erchonia.com
Date Prepared
09/01/2022
Device Information
Trade Name: Erchonia® GVL Model#: GVL Common Name: Infrared Lamp Classification Name: Powered Light-Based Laser Non-Thermal with Non-Heating Effect for Adjunctive Use in Pain Therapy (21 CFR 890.5500) Classification: Class II Panel: Physical Medicine Product Code: NHN, GEX
Predicate Device
Erchonia® EVRL (Model# EVRL) cleared under K191257.
Reference Device
Erchonia® EVRL (Model# EVRL) cleared under K152196.
The use of this reference device provides the regulatory background of the safety and effectiveness of Erchonia low-level lasers in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
The Erchonia® PL2000, a red (635 nm) diode laser was evaluated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin in a doubleblinded, sham-controlled, randomized clinical trial, the results of which successfully supported an
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FDA clearance under K012580 for the following indication:
"The TUCO Erchonia PL2000 is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin."
The TUCO Erchonia PL2000 was subsequently renamed the Erchonia® EVRL (reference device), and its indications updated under K152196 to include both the treatment of neck and shoulder pain as well as acne vulgaris, as follows:
"The Erchonia EVRL Laser is generally indicated: a. while using the red diode, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, and b. while using the blue diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris"
Device Description
The Erchonia® GVL (Model# GVL) is identical to the predicate device, the Erchonia® EVRL cleared under K191257, including device enclosure, functionally and software. The only difference between the Erchonia® GVL and the Erchonia® EVRL is the color of laser emission (green and violet as a replacement for red and violet).
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