# K972575: 800 Series Surgical Laser System Orion Series Surgical Laser System Angled Delivery Devices

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Jul 17, 1998 after 372 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: 1 generation back to K912538 (1991). 4 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912538: KTP/Yag Plus, Laserscope (1991) Summary page 2.
- K933880: SL Series Surgical Laser Systems, Laserscope (1994) Summary page 2.
- K920589: Angled Delivery Device, Laserscope (1992) Summary page 2.
- K924644: Endostats, Microstats, Accustats, Laserscope (1993) Summary page 2.

## Most influential descendants
- K062363: BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NM (2007), 11 descendants of its own
- K082721: Laserpro 810, 940 and 980 Diode Laser Systems (2008), 7 descendants of its own
- K151890: Medical Diode Laser Systems (2015), 3 descendants of its own
- K252063: Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) (2025), 0 descendants of its own
- K243141: Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) (2024), 0 descendants of its own

## Indications for use
The 800 Series Surgical Laser Systems and Accessories are intended for use in cutting, coagulating and vaporizing prostatic tissues during treatment of benign prostatic hyperplasia (BPH) in men 50 years of age or older with prostatic volumes of 60cc or less. Ablation and hemostasis are performed with Nd:YAG wavelength (1064 nm). Vaporization is performed with the KTP wavelength (532 nm). Specific indications include: laser prostatectomy, visual laser ablation of the prostate (VLAP), obstructive voiding symptoms, obstructive prostatic adenoma, prostatic enlargement, prostatic adenoma and bladder outlet obstruction due to BPH. The device is not intended to treat prostate cancer. The Orion Series Surgical Laser Systems and Accessories are intended for use in cutting, coagulating and vaporizing prostatic tissues during treatment of benign prostatic hyperplasia (BPH) in men 50 years of age or older with prostatic volumes of 60cc or less. Ablation and hemostasis are performed with Nd:YAG wavelength (1064 nm). Vaporization is performed with the KTP wavelength (532 nm). Specific indications include: laser prostatectomy, visual laser ablation of the prostate (VLAP), obstructive voiding symptoms, obstructive prostatic adenoma, prostatic enlargement, prostatic adenoma and bladder outlet obstruction due to BPH. The device is not intended to treat prostate cancer.

Source page: https://510kreport.com/device/K972575
Methodology: https://510kreport.com/methodology