510(k) · Cleared
Cleared800 Series Surgical Laser System Orion Series Surgical Laser System Angled Delivery Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laserscope · GEX Powered Laser Surgical Instrument
Cleared on Jul 17, 1998 as substantially equivalent to K912538 (Laserscope, 1991) and 3 other predicates after a 372-day review. Its family tree reaches back 1 generation to 1991. 12 later devices descend from it.
- Decided
- Jul 17, 1998
- Review
- 372 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K912538 (1991). 4 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK912538 KTP/Yag PlusLaserscope · 1991
- This deviceK972575 800 Series Surgical Laser System Orion Series Surgical Laser System…Laserscope · 1998
- Descendant · cites it directly · 11 of its ownK062363 BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NMB&W Tek, Inc. · 2007
- Descendant · 2 generations on · 7 of its ownK082721 Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 3 of its ownK151890 Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015
- Descendant · 4 generations on · 0 of its ownK252063 Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser…Wuhan Dimed Laser Technology Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK243141 Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D…Jiangxi Medex Technology Co., Ltd. · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K062363BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NMB&W Tek, Inc. · 2007 · cites it directly11descendants
- K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc. · 2008 · 2 generations on7descendants
- K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015 · 3 generations on3descendants
- K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd. · 2025 · 4 generations on0descendants
- K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912538 | KTP/Yag Plus | Laserscope | 1991 | — |
| 0 (this device) | K972575 | 800 Series Surgical Laser System Orion Series Surgical Laser System Angled… | Laserscope | 1998 | — |
| +1 | K062363 | BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NM | B&W Tek, Inc. | 2007 | — |
| +2 | K082721 | Laserpro 810, 940 and 980 Diode Laser Systems | Photo Medex, Inc. | 2008 | 1 |
| +3 | K151890 | Medical Diode Laser Systems | Wuhan Gigaa Optronics Technology Co., Ltd. | 2015 | — |
| +4 | K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems… | Wuhan Dimed Laser Technology Co., Ltd. | 2025 | — |
| +3 | K243141 | Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810)… | Jiangxi Medex Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K912538 | KTP/Yag PlusSummary page 2…COMPARISON WITH PREDICATE DEVICE: The Laserscope KTP/Nd:YAG Surgical Laser Systems and Angled Delivery Devices are substantially equivalent to the devices cleared under K912538, K933880, K920589 and K924644. The risks and benefits for the Laserscope KTP/Nd:YAG Surgical Laser Systems and Angled Delivery D… | 1991 |
| * | K933880 | SL Series Surgical Laser SystemsSummary page 2…N WITH PREDICATE DEVICE: The Laserscope KTP/Nd:YAG Surgical Laser Systems and Angled Delivery Devices are substantially equivalent to the devices cleared under K912538, K933880, K920589 and K924644. The risks and benefits for the Laserscope KTP/Nd:YAG Surgical Laser Systems and Angled Delivery Devices ar… | 1994 |
| * | K920589 | Angled Delivery DeviceSummary page 2…EDICATE DEVICE: The Laserscope KTP/Nd:YAG Surgical Laser Systems and Angled Delivery Devices are substantially equivalent to the devices cleared under K912538, K933880, K920589 and K924644. The risks and benefits for the Laserscope KTP/Nd:YAG Surgical Laser Systems and Angled Delivery Devices are compara… | 1992 |
| * | K924644 | Endostats, Microstats, AccustatsSummary page 2…CE: The Laserscope KTP/Nd:YAG Surgical Laser Systems and Angled Delivery Devices are substantially equivalent to the devices cleared under K912538, K933880, K920589 and K924644. The risks and benefits for the Laserscope KTP/Nd:YAG Surgical Laser Systems and Angled Delivery Devices are comparable to the p… | 1993 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 4 ancestors has a recall.
- Of its descendants, K062363 (B&W Tek, Inc., 2007) has gone furthest, with 11 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (196 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972575: 800 Series Surgical Laser System Orion Series Surgical Laser System Angled Delivery Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972575
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026