# K211534: RevoLix HTL

- Pathway: 510(k) (Traditional)
- Applicant: Lisa Laser Products GmbH
- Decided: May 19, 2022 after 366 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: 7 generations back to K936109 (1994). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132975: Sphinx JR, Allmed Systems, Inc. (2014) Summary page 4.
- K110941: Revolix JR 30, Revolix JR 50, Revolix JR 160, Revolix FR 200, Allmed Systems, Inc. (2013) Summary page 4.

## Indications for use
Soft tissue treatments and lithotripsy in the field of urology: In CW mode the indications for use are: Enucleation of the prostate Vaporization of the prostate Opening of ureter and urethral strictures Bladder neck incisions Bladder tumor resections Ureter and kidney tumor ablation Condyloma and penile tumor excision In PULSED mode the indications for use are: Lithotripsy of bladder, ureter and kidney stones including fragmentation and dusting

Source page: https://510kreport.com/device/K211534
Methodology: https://510kreport.com/methodology