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NaturaLase CO2 Laser System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K152529

by Focus Medical, LLC

Identifiers

510(k) Number
K152529 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

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

The NaturaLase CO2 Laser System is a fractional ablative resurfacing device. It utilizes CO2 laser technology to provide the benefits of traditional resurfacing with the advantages of fractional technology.

This device is authorized under FDA 510(k) clearance. It is intended for use in general and plastic surgery applications.

Frequently asked questions

What is the primary clinical application for the NaturaLase CO2 Laser System?

The NaturaLase CO2 Laser System is designed for fractional ablative resurfacing. It is indicated for use in general and plastic surgery applications, providing the benefits of traditional resurfacing combined with the advantages of fractional laser technology.

What is the regulatory status of this device?

The NaturaLase CO2 Laser System is authorized under FDA 510(k) clearance, identified by K-number K152529. This indicates that the device has been determined to be substantially equivalent to a predicate device for its intended use in surgery.

Who is the manufacturer of the NaturaLase CO2 Laser System?

The device is manufactured by Focus Medical, LLC, located in Bethel, Connecticut. They are the applicant of record for the 510(k) clearance submission.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NaturaLase CO2 — FOCUS MEDICAL, Focus Medical, NATURALASE CO2 LASER SYSTEM by FOCUS MEDICAL, LLC. | FDA 510 (k) Summary

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Focus Medical, LLC

Sources (1)

  • FDA 510(k) K152529 24 fields · synced Sep 26, 2026