Chrysalis Intelligence · Product Codes · ONO

ONO · Neurosurgical Laser With Mr Thermography

General, Plastic Surgery · 8 clearances · 3 unique sponsors

Device class
Class II
Regulation 878.4810
Total clearances
8
2022-01-07 → 2026-09-03
Last 12 months
3
Unique sponsors
3
Definition

What is Neurosurgical Laser With Mr Thermography

Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery.
Medical specialty
General, Plastic Surgery
Review panel
NE
Regulation number
878.4810
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Medtronic Navigation, Inc. 3 1 2026-03-13
Monteris Medical 3 2 2026-09-03
Clinical Laserthermia Systems, AB 2 0 2025-09-04
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
61736 CPT — Medium Stereotactic laser ablation of lesion, intracranial, percutaneous, open, or via burr hole(s); initial lesion
61751 CPT — Low Stereotactic aspiration, biopsy, or lesion excision through burr hole(s); intraoperative neuronavigation with frameless stereotaxic guidance
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-09-03 K262315 Monteris Medical NeuroBlate System
2026-04-23 K260976 Monteris Medical NeuroBlate System
2026-03-13 K253391 Medtronic Navigation, Inc. Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)
2025-09-04 K251298 Clinical Laserthermia Systems, AB Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)
2025-05-29 K250307 Medtronic Navigation Visualase V2 MRI-guided Laser Ablation System (9736422)
2024-06-04 K240877 Monteris Medical, Monteris Medical NeuroBlate System
2022-09-22 K214125 Clinical Laserthermia Systems, AB TRANBERG Thermoguide Therapy System
2022-01-07 K211269 Medtronic Navigation, Inc. Visualase MRI-Guided Laser Ablation System (SW 3.4)