# UltraClear Laser System

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/ultraclear-laser-system-n-a-gex>
- Manufacturer: [Acclaro Corporation](https://devicerts.com/manufacturers/acclaro-corporation) (United States)
- Name in the registry: UltraClear Laser System (N/A)
- Device class: Class II (US FDA)
- FDA product code: GEX

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The UltraClear Laser System is a Fractional Laser Device (Product Code: GEX) designed for dermatological soft tissue ablation, coagulation, and resurfacing. It employs a 2910 nm laser to deliver controlled energy for skin resurfacing, collagen remodeling, and treatment across various skin types through fractional ablation.

This transportable system features a 15-inch touch screen for user-defined settings, integrated laser module, scanner drivers, and software controls. Supplied as a reusable medical device, it is cleared under FDA 510(k) K233803 and MDR, intended for use in clinical settings by trained professionals. No sterility or single-use designation is specified in the regulatory data.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K233803 · decision 2024-05-08 · decision SESE · status: Active
- **EUDAMED** · CE/MDR · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K233803 [FDA 510(k)]
- FDA product code: GEX [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 878.4810 [FDA 510(k)]
- Advisory committee: General, Plastic Surgery [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: UltraClear Laser System, Acclaro Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/ultraclear-laser-system-n-a-gex (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/ultraclear-laser-system-n-a-gex.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/ultraclear-laser-system-n-a-gex
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.