# K050412: Vapormax

- Pathway: 510(k) (Traditional)
- Applicant: Trimedyne, Inc.
- Decided: Mar 14, 2005 after 24 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: 6 generations back to K936109 (1994). 36 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915223: Metal Enclosed Side Firing Fibers, Trimedyne, Inc. (1992) Summary page 1.
- K992230: Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HP, Trimedyne, Inc. (1999) Summary page 1.
- K022655: Trimedyne Side Firing Needle with Vent Sheath, Trimedyne, Inc. (2002) Summary page 1.
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices, Lumenis (2001)
- K990947: Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND: Yag Surgical Lasers and  Delivery, Lumenis, Inc. (1999) Summary page 1.

## Most influential descendants
- K053457: Vapormax II (2005), 1 descendant of its own
- K233157: VaporMAX LDD; MOJo LDD; MegaJOULE LDD (2024), 0 descendants of its own

## Indications for use
The VAPoRMAX is intended for surgical use including: incision, excision, vaporization, ablation, and coagulation of soft tissue. The VAPORMAX is indicated for use with any cleared Holmium:YAG 2.1 micrometer laser with a compatible connector for that laser's cleared indications for use.

Source page: https://510kreport.com/device/K050412
Methodology: https://510kreport.com/methodology