# K213554: Sentient Manufacturing Laser Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Sentient Manufacturing, LLC
- Decided: Feb 2, 2022 after 86 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K100597: Harmonic Focus Shears, Ethicon Endo-Surgery, LLC (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Sentient Manufacturing Laser Fiber System is intended to deliver the laser radiation to the target tissue when used with any cleared/certified surgical laser with operational wavelength between 500nm - 2200nm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.

Source page: https://510kreport.com/device/K213554
Methodology: https://510kreport.com/methodology