(108 days)
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No
The summary describes a laser device for heat therapy and pain relief. There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The device description focuses on the physical characteristics and function of the laser.
Yes
The device is intended to treat specific medical conditions (muscle and joint pain, stiffness, arthritis pain, muscle spasm) and promote physiological changes (increase local blood circulation, muscle relaxation), which aligns with the definition of a therapeutic device.
No
The "Intended Use / Indications for Use" states that the device is intended for "providing topical heating for the purpose of elevating tissue temperature for temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle." This describes a therapeutic, not a diagnostic, function.
No
The device description clearly outlines a hardware device (Nd:YAG laser, Infrared Lamp system) with electrical requirements and different treatment configurations involving physical contact or non-contact handpieces. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "topical heating for the purpose of elevating tissue temperature for temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle." This describes a therapeutic device that acts directly on the body, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description details a laser system that emits a specific wavelength of light for heat therapy. This aligns with a physical therapy or pain management device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
In summary, the HILT Family Laser is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HILT Family Laser is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
Product codes
ILY
Device Description
The HILT Family Laser provides 1,064 nm wavelength. Laser emission activation is by used selectable controller. Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.
The Hilt Family Laser: HILT I, HILT III is a Nd:YAG laser, Intrared Lamp system for heat therapy. The three possible treatment configurations are initalou Eamp Hilt II, non-contact; Hilt III, both contact and non-contact. The noncontact hand piece utilizes a spacer between the output window and the skin of the patient.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Nonclinical Performance Data: none
Clinical Performance Data: none
Key Metrics
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Predicate Device(s)
MLT-1000 IR Laser System
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
SEP 2 6 2005
510(K) Summary
| | SEP 26 2005 | K051537
p. 1 of 1 |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Submitter: | 510(K) Summary
El En
Via Baldanzese, 17-50041 | |
| Contact:
Date Summary Prepared:
Device Trade Name: | Calenzano (Florence), Italy
Andrea Tozzi
Director, Quality Assurance
June 9, 2005
HILT Family Laser | |
| Common Name: | Nd:YAG laser | |
| Classification Name: | Infrared Lamp
21 CFR 890.5500 | |
| Equivalent Device: | MLT-1000 IR Laser System | |
| Device Description: | The HILT Family Laser provides 1,064 nm wavelength. Laser
emission activation is by used selectable controller. Electrical
requirement is 230 VAC, 15A, 50-60 Hz, single phase. | |
| Intended Use: | The HILT Family Laser is intended to provide topical heating for the
purpose of elevating tissue temperature for temporary relief of muscle
and joint pain and stiffness, arthritis pain, or muscle spasm, the
temporary increase in local blood circulation and/or promoting | |
| Comparison: | relaxation of muscle.
The HILT Family Laser has the same indications for use, the same
principle of operation, and similar performance specifications as the
predicate devices. | |
| Nonclinical Performance Data: | none | |
| Clinical Performance Data: | none | |
| Conclusion:
Additional Information: | The HILT Family Laser is a safe and effective device for the
indications specified.
none | |
1
Name of Manufacturer: El En SpA (Italy), represented by Cynosure, Inc.
Laser Model Name and Number: HILT Family Laser: HILT I, HILT II, HILT III; Nd: YAG laser, Infrared Lamp System.
Laser Type: (Circle all that apply) Luser Type: \ Prescriptive Use X OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara BonettD for MKM
Division of General, Restorative. and Neurological Devices
510(k) Number K051537