# K233157: VaporMAX LDD; MOJo LDD; MegaJOULE LDD

- Pathway: 510(k) (Traditional)
- Applicant: Innovaquartz, LLC
- Decided: May 3, 2024 after 219 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
Longest line of descent: 23 generations back to K943450 (1995). 413 ancestors in all.
No later device cites it as a predicate yet.
0 of 414 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053457: Vapormax II, Trimedyne, Inc. (2005) Summary page 5.
- K170366: Laser Peripherals, LLC Family of Bare Laser Fibers, Laser Peripherals, LLC (2017) Summary page 5.

## Indications for use
The VaporMAX LDD® family of laser fibers, which includes VaporMAX LDD, MegaJOULE LDD and MoJO LDD, are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500 nm and 2200 nm have received regulatory clearance. The VaporMAX LDD family of laser delivery fibers are intended for use with any cleared surgical laser having a SMA 905 connector, SMA 906 connector or manufacturer specific connectors and adaptors.

Source page: https://510kreport.com/device/K233157
Methodology: https://510kreport.com/methodology