Chrysalis Intelligence · Product Codes · ONO

ONO · Unclassified

7 clearances · 3 unique sponsors

Device class
Regulation —
Total clearances
7
2022-01-07 → 2026-04-23
Last 12 months
3
Unique sponsors
3
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
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
Clinical Laserthermia Systems, AB 2 1 2025-09-04
Monteris Medical 2 1 2026-04-23
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
2026-04-23 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)