Facility

CLINICAL LASERTHERMIA SYSTEMS AB

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3012452798
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	Scheelevagen 2 Lund Skane, SE 22381
Registration status	Active · expires 2026
Parent company	Clinical Laserthermia Systems AB (owner-operator 10050452)
Brand names	Tranberg CLS Thermal Therapy System

Activity by year

Recalls (1)

Devices registered here (1)

Powered Laser Surgical Instrument
Product code GEX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810

Recalls & enforcement

Class IITerminated2021-04-01
single use devices labeled as sterile may not have been adequately sterilized

All facilities operated by Clinical Laserthermia Systems AB

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CLINICAL LASERTHERMIA SYSTEMS AB (FEI 3012452798) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012452798-clinical-laserthermia-systems-ab/

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