# K010715: AL-40

- Pathway: 510(k) (Traditional)
- Applicant: Ddc Technologies, Inc.
- Decided: Oct 4, 2001 after 209 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.
59 later devices descend from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K090571: Alma Lasers ALEX755 Module (2009), 58 descendants of its own
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own
- K143519: The MeDioStar NeXT Family (2015), 32 descendants of its own
- K172193: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules (2018), 22 descendants of its own
- K222064: The Alma Soprano Titanium (2022), 14 descendants of its own

Source page: https://510kreport.com/device/K010715
Methodology: https://510kreport.com/methodology