Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Used for incision/excision, ablation, and coagulation (hemostasis) when attached to a cleared Ho:YAG laser system comprised of any standard SMA-type connector and an output power of up to 100 watts, for the indications for which the system has been cleared.
Used for incision/excision, ablation, and coagulation (hemostasis) when attached to a cleared Ho:YAG laser system comprised of any standard SMA-type connector and an output power of up to 100 watts, for the indications for which the system has been cleared.
The device was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of: 1. Tensile Testing – Testing shows the tensile force during proper clinical use should not fracture the materials and/or bonds. 2. Bend Radius Testing – Testing shows that the fibers met the minimum bend radius requirements. 3. Energy Transmission Testing – Testing shows that fibers transmit laser energy with not more than 20% loss from laser output to fiber output. 4. Accelerated Aged Testing – Testing shows that devices accelerated-aged to the equivalent of three years meet performance requirements for tensile, bend radius, and energy transmission testing.
Summary parsed at:2026-06-01 06:09:56 UTC
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K133788 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K133788 as a predicate
