Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810) → ONO — Neurosurgical Laser With Mr Thermography

# ONO · Neurosurgical Laser With Mr Thermography

_General, Plastic Surgery · 21 CFR 878.4810 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONO

## Overview

- **Product Code:** ONO
- **Device Name:** Neurosurgical Laser With Mr Thermography
- **Regulation:** [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## 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.

## Classification Rationale

(1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253391](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONO/K253391.md) | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) | Medtronic Navigation, Inc. | Mar 13, 2026 | SESE |
| [K251298](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONO/K251298.md) | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) | Clinical Laserthermia Systems, AB | Sep 4, 2025 | SESE |
| [K250307](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONO/K250307.md) | Visualase V2 MRI-guided Laser Ablation System (9736422) | Medtronic Navigation | May 29, 2025 | SESE |
| [K240877](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONO/K240877.md) | Monteris Medical NeuroBlate System | Monteris Medical, | Jun 4, 2024 | SESE |
| [K214125](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONO/K214125.md) | TRANBERG Thermoguide Therapy System | Clinical Laserthermia Systems, AB | Sep 22, 2022 | SESE |
| [K211269](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONO/K211269.md) | Visualase MRI-Guided Laser Ablation System (SW 3.4) | Medtronic Navigation, Inc. | Jan 7, 2022 | SESE |

## Top Applicants

- Clinical Laserthermia Systems, AB — 2 clearances
- Medtronic Navigation, Inc. — 2 clearances
- Medtronic Navigation — 1 clearance
- Monteris Medical, — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONO](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONO)

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