Chrysalis Intelligence · Sponsors · Clinical Laserthermia Systems, AB

Clinical Laserthermia Systems, AB

Lund, SE · 3 510(k) clearances · 3 recalls

Total clearances
3
2021-03-26 → 2025-09-04
Last 12 months
1
Product codes
2
Most recent
2025-09-04
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
ONO 2 2025-09-04
GEX Powered Laser Surgical Instrument Class II General, Plastic Surgery 1 2021-03-26
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
0
Most recent
2021-04-01
DateSeverityStatusRecall # ProductCodeReason
2021-04-01 Class II Terminated Z-1782-2021 Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usa… single use devices labeled as sterile may not have been adequately sterilized
2021-04-01 Class II Terminated Z-1781-2021 Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Intr… single use devices labeled as sterile may not have been adequately sterilized
2021-04-01 Class II Terminated Z-1780-2021 Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device … single use devices labeled as sterile may not have been adequately sterilized
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2025-09-04 K251298 Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) ONO
2022-09-22 K214125 TRANBERG Thermoguide Therapy System ONO
2021-03-26 K201466 Tranberg CLS Laser Applicator GEX Class II General, Plastic Surgery