510(k) · Cleared
ClearedMegabeam Reusable Fiber Optic Handpiece and Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceram Optec, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 29, 1998 as substantially equivalent to K923953 (Ceram Optec, Inc., 1992) and 3 other predicates after a 177-day review. Its family tree reaches back 2 generations to 1991. 3 later devices descend from it.
- Decided
- Jul 29, 1998
- Review
- 177 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K904627 (1991). 20 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
- 1 generation backK960032 Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group · 1996
- This deviceK980389 Megabeam Reusable Fiber Optic Handpiece and NeedlesCeram Optec, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK061025 Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK090281 Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK060905 Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1Iridex Corp · 2006
Most influential descendants
Showing 3 of 3 · See all- K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006 · cites it directly1descendant
- K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009 · 2 generations on0descendants
- K060905Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1Iridex Corp · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904627 | Centauri Yag Laser Syst, Ear, Nose , Throat | Pfizer Laser Systems | 1991 | — |
| −1 | K960032 | Coherent Versapulse Aesthetic Surgical Lasers | Coherent Medical Group | 1996 | — |
| 0 (this device) | K980389 | Megabeam Reusable Fiber Optic Handpiece and Needles | Ceram Optec, Inc. | 1998 | — |
| +1 | K061025 | Accutech Endolite Probe | Accutech Medical Technologies, Inc. | 2006 | — |
| +2 | K090281 | Accutech Family of Powerflex Laser Delivery Devices | Accutech Medical Technologies, Inc. | 2009 | — |
| +1 | K060905 | Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1 | Iridex Corp | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 8 | 0 |
| 1995 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 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? (5)
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 |
|---|---|---|---|
| * | K923953 | MegabeamSummary page 1…er Fiber Optic Delivery System Handpiece; J Classification Name Accessory to Laser Surgical Instruments Predicate Devices CeramOptec’s original disposable handpieces (K923953), CeramOptec’s disposable arthroscopy handpiece (K946336); CeramOptec’s disposable general surgery straight handpiece and adjust… | 1992 |
| * | K946336 | Megabeam Fiber Optic Delivery SystemSummary page 1…on Name Accessory to Laser Surgical Instruments Predicate Devices CeramOptec’s original disposable handpieces (K923953), CeramOptec’s disposable arthroscopy handpiece (K946336); CeramOptec’s disposable general surgery straight handpiece and adjustable handpiece (K943445); TTI Medical’s Optic Handpiece;… | 1995 |
| * | K943445 | Megabeam Fiber Optic Delivery SystemSummary page 1…able handpieces (K923953), CeramOptec’s disposable arthroscopy handpiece (K946336); CeramOptec’s disposable general surgery straight handpiece and adjustable handpiece (K943445); TTI Medical’s Optic Handpiece; and Coherent Medical’s VersaLink reusable handpiece (K960032). N\\DC - 61213/1 - 0575588.01 ==… | 1994 |
| * | K960032 | Coherent Versapulse Aesthetic Surgical LasersSummary page 1…’s disposable general surgery straight handpiece and adjustable handpiece (K943445); TTI Medical’s Optic Handpiece; and Coherent Medical’s VersaLink reusable handpiece (K960032). N\\DC - 61213/1 - 0575588.01 Intended Use The MegaBeam Reusable Fiber Optic Handpiece and Needles are intende… | 1996 |
| * | — | TTI Medical’s Optic Handpiece Named without a submission number |
What descends from it? (3)
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 7 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K061025 (Accutech Medical Technologies, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K923953.
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?
Intended to be used as a fiber optic delivery system handpiece with the capability to be reused with a disposable optical fiber.
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/K980389 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980389: Megabeam Reusable Fiber Optic Handpiece and Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980389
Report an extraction error
Are you the manufacturer?
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