Class Class II

Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) (K242755)

K242755 2025-05-19 Traditional
Home/ Devices/ Medical Diode Laser Systems…

Description

Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) by Gigaalaser Company , Ltd., an FDA 510(k) cleared physical medicine device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242755
Clearance Date2025-05-19
Clearance TypeTraditional
Product CodeILY
Regulation Number890.5500

Need More Information?

Contact the manufacturer or request a quote for this device.

Request Quote

Predicate lineage for K242755

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) (K242755) cites 4 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K230047Medical Diode Laser SystemsGigaalaser Company , Ltd.2024
K150138Aspen Laser Systems Therapy Laser SystemAspen Laser Systems, LLC2015
K142078VELASII THERAPY LASER SYSTEMAspen Laser Systems, LLC2014
K121363DIOWAVE LOW LEVEL COLD LASER SYSTEMTechnological Medical Advancments, ...2012

Trace the full predicate network for K242755

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

Scroll to Top