510(k) · Cleared
ClearedLaserpro Diode Laser Systems, Models 810, 940 & 980
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Photo Medex, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 5, 2004 as substantially equivalent to K023543 (Diomed, Inc., 2002) and 2 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1995. 306 later devices descend from it.
- Decided
- May 5, 2004
- Review
- 89 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K952661 (1995). 3 ancestors in all. 306 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK952661 SLT Thermalite Diode Laser Series, Diode 980, 810, 940Surgical Laser Technologies, Inc. · 1995
- This deviceK040294 Laserpro Diode Laser Systems, Models 810, 940 & 980Photo Medex, Inc. · 2004
- Descendant · cites it directly · 303 of its ownK042211 Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSurgical Laser Technologies, Inc. · 2004
- Descendant · cites it directly · 299 of its ownK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- Descendant · 2 generations on · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- Descendant · 2 generations on · 230 of its ownK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- Descendant · 2 generations on · 229 of its ownK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
Showing 5 of 306 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 306 · See all- K042211Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSurgical Laser Technologies, Inc. · 2004 · cites it directly303descendants
- K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA · 2006 · cites it directly299descendants
- K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · 2 generations on263descendants
- K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · 2 generations on230descendants
- K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · 2 generations on229descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952661 | SLT Thermalite Diode Laser Series, Diode 980, 810, 940 | Surgical Laser Technologies, Inc. | 1995 | — |
| 0 (this device) | K040294 | Laserpro Diode Laser Systems, Models 810, 940 & 980 | Photo Medex, Inc. | 2004 | — |
| +1 | K042211 | Modification to: Laserpro 810, 940, and 980 Diode Diode Laser Systems | Surgical Laser Technologies, Inc. | 2004 | — |
| +1 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| +2 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| +2 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| +2 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 8 | 0 |
| 2009 | 7 | 0 |
| 2010 | 10 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 13 | 0 |
| 2016 | 11 | 0 |
| 2017 | 12 | 0 |
| 2018 | 15 | 0 |
| 2019 | 13 | 0 |
| 2020 | 20 | 0 |
| 2021 | 12 | 0 |
| 2022 | 25 | 0 |
| 2023 | 17 | 0 |
| 2024 | 31 | 0 |
| 2025 | 46 | 0 |
| 2026 | 24 | 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? (3)
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 |
|---|---|---|---|
| * | K023543 | Evlt Kit and D15PLUS and D30PLUS DiodeSummary page 1…laser * Trade or proprietaryname: LaserPro Diode Surgical Laser System 3. PREDICATE DEVICES Diode Surgical Laser Systems * Diomed D15 & D30 Laser Systems (K023543) * Premier Aurora Laser System (K(9543 16) * SLT Thermalite 810, 940 & 980 Laser Systems (1(952661) 4. DEVICE DESCRIPT… | 2002 |
| * | K954316 | Aurora Surgical Diode Laser System W/AccessoriesSummary page 2…es, and therefore are substantially equivalent to the predicate devices which includes the Diomed D15 & D30 Laser Systems (K023543), the Premier Aurora Laser System (K954316), and the SLT Thermalite 810, 940 & 980 Laser Systems (K952661). 7. SAFETY AND EFECTIVENESS The PhotoMedex LaserPro 810. 94… | 1995 |
| * | K952661 | SLT Thermalite Diode Laser Series, Diode 980, 810, 940Summary page 2…devices which includes the Diomed D15 & D30 Laser Systems (K023543), the Premier Aurora Laser System (K954316), and the SLT Thermalite 810, 940 & 980 Laser Systems (K952661). 7. SAFETY AND EFECTIVENESS The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems are designed, tested and manufact… | 1995 |
What descends from it? (306)
See all 3065 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042211 | Modification to: Laserpro 810, 940, and 980 Diode Diode Laser Systems | 2004 | 303 |
| K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are… | 2006 | 299 |
| K082721 | Laserpro 810, 940 and 980 Diode Laser Systems | 2008 | 7 |
| K071896 | Fox 940, Model 940 | 2008 | 0 |
| K071815 | Noveon, Model LS1100-01-0968 | 2007 | 0 |
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?
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 PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are intended for delivery of laser light in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy)…
Read the full statement (130 words)
The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are intended for delivery of laser light in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are generally indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, hemostasis or coagulation of soft tissue in surgical procedures in medical specialties including: dermatology, gastroenterology, general surgery (including specific treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein), genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040294: Laserpro Diode Laser Systems, Models 810, 940 & 980.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040294
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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