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Equinox CO2 Laser System

by Eclipsemed Global, Inc. 510(k)

Active United States

510(k) K100487

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100487 Date29 Nov 2010ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

Overview

AI-generated summary, 22 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 Equinox CO2 Laser System is a powered laser surgical instrument with microbeam fractional output. It is classified as a Class II device under regulation number 878.4810 and is intended for use in general and plastic surgery procedures.

The system was cleared via the FDA 510(k) pathway under K100487 with a traditional clearance type and a substantially equivalent decision. It is manufactured by Eclipsemed Global, Inc. and is authorized for marketing in the United States.

Other devices from Eclipsemed Global, Inc.

  • Fusion System

    Class II

Questions

AI-generated answers, 22 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 is the Equinox CO2 Laser System intended for?

    The Equinox CO2 Laser System is intended for use in general and plastic surgery procedures as a powered laser surgical instrument with microbeam fractional output, based on its FDA 510(k) clearance.

  • How was the Equinox CO2 Laser System cleared for marketing?

    The Equinox CO2 Laser System was cleared via the FDA 510(k) pathway under submission K100487 with a traditional clearance type and a substantially equivalent decision, as stated in its authorization data.

  • What regulatory classification does the Equinox CO2 Laser System have?

    The Equinox CO2 Laser System is classified as a Class II device under regulation number 878.4810, as indicated in its device specifications and FDA classification data.