510(k) · Cleared
ClearedAccutech Family of Powerflex Laser Delivery Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accutech Medical Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 4, 2009 as substantially equivalent to K061025 (Accutech Medical Technologies, Inc., 2006) and 3 other predicates after a 27-day review. Its family tree reaches back 6 generations to 1989.
- Decided
- Mar 4, 2009
- Review
- 27 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K894841 (1989). 75 ancestors in all, the oldest K812219 (1981). No later device cites it as a predicate yet.
- Root · 6 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 5 generations backK960971 Oculight GLIriderm Div. · 1996
- 4 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 3 generations backK032357 Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2003
- 2 generations backK052526 Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005
- 1 generation backK061025 Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006
- This deviceK090281 Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −5 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −4 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −3 | K032357 | Novus TTX Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2003 | — |
| −2 | K052526 | Novus 3000 Laser System and Delivery Devices | Lumenis, Inc. | 2005 | — |
| −1 | K061025 | Accutech Endolite Probe | Accutech Medical Technologies, Inc. | 2006 | — |
| 0 (this device) | K090281 | Accutech Family of Powerflex Laser Delivery Devices | Accutech Medical Technologies, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 2 | 0 |
| 1984 | 2 | 0 |
| 1986 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 3 | 0 |
| 1991 | 8 | 0 |
| 1992 | 1 | 0 |
| 1993 | 5 | 0 |
| 1994 | 12 | 0 |
| 1995 | 6 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K061025 | Accutech Endolite ProbeSummary page 1…ivery Devices Primary Classification Names: Accessory for, Laser Powered Surgical Instruments III. Predicate Devices * Accutech EndoLite Probe (K06 1025) * Cook Urological OptiLite~m Holmium Laser Fibers (K073496); * FiberTech (FT) Fiber Optic Delivery Systems (K0… | 2006 |
| * | K073496 | Optilite Holmium Laser FibersSummary page 1…Laser Powered Surgical Instruments III. Predicate Devices * Accutech EndoLite Probe (K06 1025) * Cook Urological OptiLite~m Holmium Laser Fibers (K073496); * FiberTech (FT) Fiber Optic Delivery Systems (K050738); * Technology Delivery Systems Maxiflex Fiberoptic En… | 2008 |
| * | K050738 | FT Fiber Optic Delivery SystemsSummary page 1…* Accutech EndoLite Probe (K06 1025) * Cook Urological OptiLite~m Holmium Laser Fibers (K073496); * FiberTech (FT) Fiber Optic Delivery Systems (K050738); * Technology Delivery Systems Maxiflex Fiberoptic Energy Delivery System (KO13 300) IV. Product De… | 2005 |
| * | K013300 | Maxiflex Fiber Optic Energy Delivery System | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 75 ancestors have a recall of any class.
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 Accutech Family of PowerFlex laser delivery devices (bare fibers, sidefire fibers, ENT fibers, and Endoprobes) are indicated for incision/ excision, ablation, and coagulation (hemostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode and Ho:YAG wavelengths (488 - 2100 nm) for the indications for which the lasers have been cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090281: Accutech Family of Powerflex Laser 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/K090281
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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