(78 days)
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Not Found
No
The device description explicitly states, "The Nuvo-Lase 660 Laser System is not a computer controlled device." This strongly indicates the absence of AI/ML.
Yes
The device is intended for use in the treatment of various vascular and pigmented lesions of the skin, indicating a therapeutic purpose.
No
The intended use is for the treatment of vascular and pigmented lesions, not for diagnosis.
No
The device description explicitly details hardware components such as a laser system, handpiece, footswitch, and power requirements, indicating it is a physical device, not software-only.
Based on the provided information, the Nuvo-Lase 660 Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the treatment of selected vascular and pigmented lesions of the skin. IVD devices are used for the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laser system designed to deliver light energy to tissue for therapeutic purposes (photocoagulation). This is a direct treatment modality, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Nuvo-Lase 660 Laser System is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Nuvo-Lase 660 Laser System is intended for use in the treatment of selected vascular and pigmented lesions of the skin. Laser light is used to photocoagulate tissue based on the absorption characteristic of the targeted chromophore within the tissue. Representative indications for use are:
Nuvo-Lase Model 660 Laser System For vascular lesions: (Green - 532 nm)
- Capillary Hemangioma (port wine hemangioma)
- Strawberry hemangioma
- Telangiectasia
- Rosacea
For pigmented lesions: (Green - 532 nm).
- Freckles
- Age Spots
- Cafe-au-lait
- Lentigo
Product codes
79GEX
Device Description
The Nuvo-Lase 660 Laser System submission covers all of the internal parts, subassemblies and components as well as the completed device. The Nuvo-Lase Model 660 is a continuous wave frequency-doubled Nd:YAG laser system with output at 532 nm.
Treatment beam output for the Nuvo-Lase 660 laser 3 Watts continuous wave at 532 nm. The aiming beam is provided by an adjustable intensity incoherent white light source. Exposure times for the Nuvo-Lase 660 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous.
Laser activation occurs by footswitch. Overall weight of the dimensions of 10 X 14 X 5 inches (25 X 36 X 13 Cm).
The electrical power requirement is 115 VAC 15 amp single phase. The system is air-cooled by fans.
Accessories available for use with the Nuvo-Lase 660 Laser include a focusing handpiece with interchangeable guide tips and/or the Hexascan Mark II. The Nuvo-Lase 660 Laser System is not a computer controlled device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Laserscope Aura, Lihtan 532
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
K 970667
Nuvo-Lase 660 Laser System American Laser Medical February 21, 1997
MAY 1 3 1997
Summary of Safety and Effectiveness Information
Regulatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807.92
Company Name/Contact;
| Company: American Laser Medical
1832 South 3850 West
Salt Lake City, UT 84104
| (801) 972-1311, FAX (801) 972-5251 | ||
|---|---|---|
| --------------------------------------------------------------------------------------------------------------------------- | -- | -- |
Mr. Daniel Hoefer Contact: Regulatory Affairs American Laser Medical 1832 South 3850 West Salt Lake City, UT 84104 (801) 972-1311, FAX (801) 972-5251
Name of Device:
Nuvo-Lase 660 Laser Bystem Trade Name:
Common Name: Dermatology Laser
Classification:
Powered surgical laser instruments are assigned the unique device classification code 79GEX. The published physical description of this device is found in 21 CFR, & 878.4810 (a) device classification section specifically This (2) • • describes argon laser systems. The American Laser Medical device is a CW 532 nm frequency doubled Nd: YAG laser system. However, for the purposes of this submission, American Laser Medical maintains that there is no substantial difference in doubled Nd:YAG and argon laser systems. CW frequency Presently, these lasers are considered Class II medical devices.
1
Nuvo-Lase 660 Laser System American Laser Medical February 21, 1997
Description of Device:
The Nuvo-Lase 660 Laser System submission covers all of the internal parts, subassemblies and components as well as the completed device. The Nuvo-Lase Model 660 is a continuous wave frequency-doubled Nd:YAG laser system with output at 532 nm.
Treatment beam output for the Nuvo-Lase 660 laser 3 Watts The aiming beam is provided by continuous wave at 532 nm. adjustable intensity incoherent white light source. an Exposure times for the Nuvo-Lase 660 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous.
Laser activation occurs by footswitch. Overall weight of the dimensions of 10 X 14 X 5 inches (25 X 36 X 13 Cm).
The electrical power requirement is 115 VAC 15 amp single The system is air-cooled by fans. phase.
Accessories available for use with the Nuvo-Lase 660 Laser include a focusing handpiece with interchangeable guide tips and/or the Hexascan Mark II. The Nuvo-Lase 660 Laser System is not a computer controlled device.
Intended Use:
The Nuvo-Lase 660 Laser System is intended for use in the treatment of selected vascular and pigmented lesions of the Laser light is used to photocoagulate tissue based on skin. the absorption characteristic of the targeted chromophore within the tissue.
Indications for Use:
The Nuvo-Lase ୧୧୦ Laser រុង intended for in use the treatment of selected pigmented and vascularized lesions of the skin. Representative indications for use are:
2
Nuvo-Lase 660 Laser System American Laser Medical February 21, 1997
Nuvo-Lase Model 660 Laser Bystem For vascular lesions: (Green - 532 nm)
- Capillary Hemangioma (port wine hemangioma) 1.
- Strawberry hemangioma 2 .
- Telangiectasia 3.
- Rosacea 4 .
For pigmented lesions: (Green - 532 nm).
- Freckles 1.
- Age Spots 2.
- Cafe-au-lait 3.
- Lentigo 4 .
Comparison of Device Characteristics:
For vascular lesions:
The Nuvo-Lase 660 Laser System is substantially equivalent to the Laserscope Aura and the Lihtan 532 already in commercial distribution. The materials, design, intended use, method of manufacture, warnings, cautions, precautions and treatment parameters are substantially the same.
For pigmented lesions:
The Nuvo-Lase 660 Laser System is substantially equivalent to the Laserscope Aura and the Lihtan 532, already in commercial distribution. The materials, design, intended use, method of manufacture, warnings, cautions, precautions and treatment parameters are substantially the same.