(199 days)
Not Found
No
The document describes a light therapy system with specific wavelengths and power outputs, focusing on hardware components and electrical/safety standards. There is no mention of AI, ML, or any data processing that would suggest the use of these technologies.
Yes
The device is described as a "pain therapy system" and is indicated for "temporary relief of minor chronic neck and shoulder pain," which are therapeutic applications.
No
The device is described as a "pain therapy system" and is indicated for "temporary relief of minor chronic neck and shoulder pain," which are therapeutic rather than diagnostic functions.
No
The device description explicitly details hardware components including a hand-held control unit, battery, and three optional applicator heads containing lasers and LEDs. It also mentions electrical safety testing and compliance with hardware-related standards.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin". This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a "pain therapy system" that utilizes light and laser technology. This aligns with a therapeutic device, not a device used to diagnose conditions by examining samples from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to apply light therapy to the body for pain relief.
N/A
Intended Use / Indications for Use
The Quantum Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is indicated for: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin using the QS-2; QS-4; and/or the QS-L applicator heads.
Product codes
NHN
Device Description
The Quantum Light Therapy System is a hand-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of both laser and light emitting diodes(LED) in three optional applicator heads. It combines the clinically accepted therapentic treatment of numerous predicate light therapy callor itsacs: It commercial distribution and 510(k) approved into one complete, compact, and costeffective system.
The system consists of a basic hand-held, battery operated control unit and three optional (one-LED; two-laser) and interchangeable applicator heads which can only be used with the Quantum Light Therapy System control unit.
The three distinct applicator heads produce wavelengths that range between 609-645mm which falls within the spectrum as defined by 21 CFR §890.5500.
The two laser applicator heads produce an output power of
§ 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.
0
Image /page/0/Picture/0 description: The image shows the word "Stargate" in bold, black letters. Above the word is a thin, black oval shape. To the right of the oval is a black star shape.
MAR 2 6 2004
Final 510(k) Summary For Application #K032816 Dated March 23, 2004
(as required per 21CFR; §807.92)
Quantum Light Therapy System
The following modified 510k summary is in response to the issues indicated by the Food and Drug Administration in a phone conversation on March 22, 2004. This represents Stargate's Final Amended Summary.
| I. Applicant | Stargate International, Inc. |
|---|---|
| 10235 South Progress Way #7 | |
| Parker, CO 80134 | |
| Phone: 303-840-8206 | |
| Fax: 303-840-8320 | |
| II. Contact Name: | Robert H. Walker; CEO |
III. Device Name
| Proprietary Name | Quantum Light Therapy System |
|---|---|
| Common/Usual Name(s) | Low Level Laser Therapy (LLLT) |
| Therapeutic Light System | |
| Classification Name | Infrared Lamp; (21CFR; §890.5500) |
| Product Code(s) | NHN |
rwalker@stargateinternational.com
IV. Predicate Device/Substantial Equivalency
The Quantum Light Therapy System is substantially equivalent to other pulsed low level therapeutic lasers and light therapy systems currently in commercial distribution. The Quantum Light Therapy System has the same intended use and similar technological characteristics to predicate devices. It combines the clinically accepted therapeutic uses of previously FDA 510(k) approved light therapy systems currently in commercial distribution into one complete, compact, and cost-effective system.
1
The technological equivalence to the predicate devices is substantiated by the wavelengths and power outputs generated by the individual Quantum System applicator heads. Depending on the applicator head chosen by the clinician, the Quantum System will provide the same treatment benefits and regimens for conditions already approved by the Food and Drug Administration.
The predicate devices the Quantum System establishes equivalence to include the following:
| Predicate Device | 510(k) # | Manufacturer |
|---|---|---|
| Tuco Erchonia PL3000 | K012580 | Tuco Innovations |
| Super Nova; Accubeam | K001179 | Light Force Therapy, Inc. |
| MedX 100 Series | K020017 | MedX Electronics, Inc. |
V. Intended Use of the Device
The Quantum Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is indicated for:
- A- Adjunctive use in providing temporary relief of minor chronic neck and shoulder paint of musculoskeletal origin using the QS-2; QS-4; and/or the QS-L applicator heads.
VI. Description of the Device
The Quantum Light Therapy System is a hand-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of both laser and light emitting diodes(LED) in three optional applicator heads. It combines the clinically accepted therapentic treatment of numerous predicate light therapy callor itsacs: It commercial distribution and 510(k) approved into one complete, compact, and costeffective system.
The system consists of a basic hand-held, battery operated control unit and three optional (one-LED; two-laser) and interchangeable applicator heads which can only be used with the Quantum Light Therapy System control unit.
The three distinct applicator heads produce wavelengths that range between 609-645mm which falls within the spectrum as defined by 21 CFR §890.5500.
2
The two laser applicator heads produce an output power of Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin using the QS-2; QS-4; and/or the QS-L applicator heads.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K132816