← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K970667 # NUVO-LASE 660 LASER SYSTEM (K970667) _American Laser Medical · GEX · May 13, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K970667 ## Device Facts - **Applicant:** American Laser Medical - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** May 13, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended 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. ## Device Story Nuvo-Lase 660 is a continuous wave (CW) frequency-doubled Nd:YAG laser system emitting at 532 nm; 3 Watts output. Device used by physicians in clinical settings for photocoagulation of skin lesions. Operator activates laser via footswitch; exposure times range from 0.02s to continuous. System includes focusing handpiece with interchangeable guide tips and optional Hexascan Mark II. Laser energy targets specific chromophores in tissue to treat vascular and pigmented lesions. Benefits include precise tissue photocoagulation for dermatological conditions. ## Clinical Evidence No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to predicate devices. ## Technological Characteristics CW frequency-doubled Nd:YAG laser; 532 nm wavelength; 3W output. Air-cooled by fans. Dimensions: 10x14x5 inches; weight: 20 lbs. Power: 115 VAC. Accessories: focusing handpiece, interchangeable guide tips, Hexascan Mark II. Non-computer controlled. ## Regulatory 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. ## Predicate Devices - Laserscope Aura - Lihtan 532 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Nuvo-Lase 660 Laser System American Laser Medical February 21, 1997 K 970667 MAY 13 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 **Contact:** Mr. Daniel Hoefer Regulatory Affairs American Laser Medical 1832 South 3850 West Salt Lake City, UT 84104 (801) 972-1311, FAX (801) 972-5251 ## Name of Device: **Trade Name:** Nuvo-Lase 660 Laser System **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) (2). This device classification section specifically 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 CW frequency doubled Nd:YAG and argon laser systems. 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 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 system is 20 lbs. (9 kg). The Nuvo-Lase 660 Laser System has 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. ## Intended 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. ## Indications for Use: The Nuvo-Lase 660 Laser is intended for use in 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 System 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 ## 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. 3 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K970667](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K970667) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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