510(k) · Cleared
ClearedOmniguide Beampath Fiber Optic Handpiece System and Sterilization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omniguide, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Aug 12, 2008 as substantially equivalent to K952006 (Tti Medical, 1995) and 1 other predicate after a 35-day review. Its family tree reaches back 5 generations to 1984. 4 later devices descend from it.
- Decided
- Aug 12, 2008
- Review
- 35 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K844002 (1984). 10 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 4 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 3 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 2 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 1 generation backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- This deviceK081939 Omniguide Beampath Fiber Optic Handpiece System and Sterilization TrayOmniguide, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK140378 Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK170777 Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation · 2017
- Descendant · 3 generations on · 0 of its ownK202880 J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation · 2021
- Descendant · cites it directly · 0 of its ownK183199 TRIO HandpieceOmniguide, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K140378Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc. · 2014 · cites it directly2descendants
- K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation · 2017 · 2 generations on1descendant
- K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation · 2021 · 3 generations on0descendants
- K183199TRIO HandpieceOmniguide, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −4 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −3 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −2 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −1 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| 0 (this device) | K081939 | Omniguide Beampath Fiber Optic Handpiece System and Sterilization Tray | Omniguide, Inc. | 2008 | — |
| +1 | K140378 | Flexguide Ultra Beampath Robotic Fiber Conduit | Omniguide, Inc. | 2014 | — |
| +2 | K170777 | Bovie J-Plasma Precise FLEX Handpiece | Bovie Medical Corporation | 2017 | — |
| +3 | K202880 | J-Plasma Precise FLEX Handpiece | Apyx Medical Corporation (Formerly Bovie Medical Corporation | 2021 | — |
| +1 | K183199 | TRIO Handpiece | Omniguide, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K952006 | Accu-Beam Fiber Optic HandpieceSummary page 1…ication Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Substantial Equivalence Claimed To: K952006, ACCU-Beam Fiber Optic Handpeice K040223 PolyVac Surgical Instrument Delivery System 15 of… | 1995 |
| * | K040223 | Polyvac Instrument Delivery SystemSummary page 1…ment for use in general and plastic surgery and in dermatology. Substantial Equivalence Claimed To: K952006, ACCU-Beam Fiber Optic Handpeice K040223 PolyVac Surgical Instrument Delivery System 15 of 66… | 2004 |
What descends from it? (4)
2 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?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K140378 (Omniguide, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K952006.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray is indicated for use in conjunction with OmniGuide's waveguide fibers to enable the surgeon to perform incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081939: Omniguide Beampath Fiber Optic Handpiece System and Sterilization Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081939
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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