ONO · Neurosurgical Laser With Mr Thermography
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | ONO |
|---|---|
| Device Name | Neurosurgical Laser With Mr Thermography |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
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 | 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 | 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 | Visualase V2 MRI-guided Laser Ablation System (9736422) | Medtronic Navigation | May 29, 2025 | SESE |
| K240877 | Monteris Medical NeuroBlate System | Monteris Medical, | Jun 4, 2024 | SESE |
| K214125 | TRANBERG Thermoguide Therapy System | Clinical Laserthermia Systems, AB | Sep 22, 2022 | SESE |
| K211269 | 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
