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Nuvo-Lase 660 Laser System

by American Laser Medical

510(k) K970667

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970667 Date13 May 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Nuvo-Lase 660 Laser System is a Class 2 laser device designed for the treatment of vascular and pigmented skin lesions. It employs laser light to selectively photocoagulate targeted tissue based on chromophore absorption, enabling precise lesion removal or reduction.

This system is supplied as a reusable medical device and is intended for use in clinical settings, including dermatology and plastic surgery. It is cleared under FDA 510(k) clearance (K970667) for General and Plastic Surgery applications, adhering to traditional regulatory pathways. No sterility or single-use specifications are noted in the data.

Other devices from American Laser Medical

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of skin conditions is the Nuvo-Lase 660 Laser System specifically designed to treat?

    The Nuvo-Lase 660 Laser System is designed for treating vascular and pigmented skin lesions. It uses laser light to selectively target and coagulate tissue based on how it absorbs light, allowing for precise removal or reduction of these lesions. This makes it suitable for conditions like spider veins, birthmarks, or other pigmented growths.

  • Is the Nuvo-Lase 660 Laser System intended for single-use or can it be reused in a clinical setting?

    The Nuvo-Lase 660 Laser System is explicitly described as a reusable medical device, meaning it is built for repeated use in clinical environments like dermatology or plastic surgery offices. Since it is not classified as single-use, proper cleaning, maintenance, and sterilization protocols must be followed between uses.

  • How is the Nuvo-Lase 660 Laser System regulated in the U.S., and what does that mean for its use?

    The Nuvo-Lase 660 Laser System is cleared under the FDA’s 510(k) pathway (K970667) as a Class 2 laser device, with a decision classification of ‘Substantially Equivalent’ to a predicate device. This means it has undergone FDA review to confirm it meets safety and effectiveness standards for general and plastic surgery applications, ensuring it adheres to established regulatory requirements for its intended clinical use.

  • What kind of clinical settings is the Nuvo-Lase 660 Laser System intended for, and why?

    The system is designed for use in clinical settings such as dermatology and plastic surgery offices. This is because it requires controlled environments with trained personnel to operate the laser safely and effectively for treating vascular and pigmented skin lesions, ensuring proper patient care and adherence to medical protocols.