510(k) · Cleared
ClearedPHOTEX30 Diode Laser Series: 980, 810, 940
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotex, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Oct 6, 2009 as substantially equivalent to K060304 (Biotex, Inc., 2006) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Oct 6, 2009
- Review
- 77 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K952661 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK952661 SLT Thermalite Diode Laser Series, Diode 980, 810, 940Surgical Laser Technologies, Inc. · 1995
- 1 generation backK060304 Photex Diode Laser Series, Models 980, 810 and 940Biotex, Inc. · 2006
- This deviceK092197 PHOTEX30 Diode Laser Series: 980, 810, 940Biotex, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK142216 Tranberg CLS Thermal Therapy SystemClinical Laserthermia Systems, AB · 2015
- Descendant · 2 generations on · 0 of its ownK201687 Avenda Health Treatment SystemAvenda Health, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952661 | SLT Thermalite Diode Laser Series, Diode 980, 810, 940 | Surgical Laser Technologies, Inc. | 1995 | — |
| −1 | K060304 | Photex Diode Laser Series, Models 980, 810 and 940 | Biotex, Inc. | 2006 | — |
| 0 (this device) | K092197 | PHOTEX30 Diode Laser Series: 980, 810, 940 | Biotex, Inc. | 2009 | — |
| +1 | K142216 | Tranberg CLS Thermal Therapy System | Clinical Laserthermia Systems, AB | 2015 | — |
| +2 | K201687 | Avenda Health Treatment System | Avenda Health, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K060304 | Photex Diode Laser Series, Models 980, 810 and 940Summary page 1…Reg.Class: II Reg. Number: 878.4810 Predicate Device PhoTex 15 Diode Laser Series: 980, 810, 940 (K060304) SLT Thermalite Diode Laser Series: 980, 810, 940 (K952661) Description of Device The PhoTex3o Diode Laser Series are… | 2006 |
| * | K952661 | SLT Thermalite Diode Laser Series, Diode 980, 810, 940Summary page 1…878.4810 Predicate Device PhoTex 15 Diode Laser Series: 980, 810, 940 (K060304) SLT Thermalite Diode Laser Series: 980, 810, 940 (K952661) Description of Device The PhoTex3o Diode Laser Series are diode lasers emitting radiation in either a continuous-wave (CW),… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142216 | Tranberg CLS Thermal Therapy System | 2015 | 1 |
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 10.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142216 (Clinical Laserthermia Systems, AB, 2015) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K060304.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 PhoTex3O Diode Laser Series is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092197: PHOTEX30 Diode Laser Series: 980, 810, 940.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092197
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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