(78 days)
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. The Nuvo-Lase 660 Laser System is intended for in use the treatment of selected pigmented and vascularized lesions of the skin. Representative indications for use are: For vascular lesions: (Green - 532 nm) 1. Capillary Hemangioma (port wine hemangioma) 2 . Strawberry hemangioma 3. Telangiectasia 4 . Rosacea For pigmented lesions: (Green - 532 nm). 1. Freckles 2. Age Spots 3. Cafe-au-lait 4 . Lentigo
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.
The provided text is a medical device summary for the Nuvo-Lase 660 Laser System. It focuses on regulatory information, device description, and intended use, particularly for vascular and pigmented lesions.
It does not contain information about acceptance criteria, device performance metrics, or any study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, or training set information).
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information about a study that proves the device meets acceptance criteria, as this information is not present in the provided text.
{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 Medical1832 South 3850 WestSalt 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.
§ 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.