Class Class II

Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) (K251298)

K251298 2025-09-04 Traditional
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Description

Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) by Clinical Laserthermia Systems, AB, an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251298
Clearance Date2025-09-04
Clearance TypeTraditional
Product CodeONO
Regulation Number878.4810

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