510(k) · Cleared
ClearedSharplan Models 20C, 30C, and 40C CO2 Lasers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sharplan Lasers, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Nov 5, 1996 after a 78-day review. The FDA summary names its predicate without a number. 397 later devices descend from it.
- Decided
- Nov 5, 1996
- Review
- 78 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
397 later devices descend from it, 7 citing it directly.
- This deviceK963229 Sharplan Models 20C, 30C, and 40C CO2 LasersSharplan Lasers, Inc. · 1996
- Descendant · cites it directly · 377 of its ownK991628 Modified LX-20 CO2 Laser System Family, LX-20SAEsc Medical Systems, Inc. · 1999
- Descendant · cites it directly · 376 of its ownK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
- Descendant · 2 generations on · 323 of its ownK030147 Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003
- Descendant · 2 generations on · 318 of its ownK031795 Reliant Laser SystemReliant Technologies, Inc. · 2003
- Descendant · 2 generations on · 316 of its ownK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
Showing 5 of 397 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 397 · See all- K991628Modified LX-20 CO2 Laser System Family, LX-20SAEsc Medical Systems, Inc. · 1999 · cites it directly377descendants
- K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc. · 2002 · cites it directly376descendants
- K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003 · 2 generations on323descendants
- K031795Reliant Laser SystemReliant Technologies, Inc. · 2003 · 2 generations on318descendants
- K040617Reliant Laser System IIReliant Technologies, Inc. · 2004 · 2 generations on316descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963229 | Sharplan Models 20C, 30C, and 40C CO2 Lasers | Sharplan Lasers, Inc. | 1996 | — |
| +1 | K991628 | Modified LX-20 CO2 Laser System Family, LX-20SA | Esc Medical Systems, Inc. | 1999 | — |
| +1 | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device… | Lumenis, Inc. | 2002 | — |
| +2 | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers | Lumenis, Ltd. | 2003 | — |
| +2 | K031795 | Reliant Laser System | Reliant Technologies, Inc. | 2003 | — |
| +2 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 10 | 0 |
| 2008 | 13 | 0 |
| 2009 | 8 | 0 |
| 2010 | 8 | 0 |
| 2011 | 14 | 0 |
| 2012 | 8 | 0 |
| 2013 | 11 | 0 |
| 2014 | 12 | 0 |
| 2015 | 12 | 0 |
| 2016 | 14 | 0 |
| 2017 | 13 | 0 |
| 2018 | 22 | 0 |
| 2019 | 12 | 0 |
| 2020 | 30 | 0 |
| 2021 | 20 | 0 |
| 2022 | 37 | 0 |
| 2023 | 25 | 0 |
| 2024 | 41 | 0 |
| 2025 | 44 | 0 |
| 2026 | 29 | 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 |
|---|---|---|---|
| * | — | Sharplan CO2 Lasers intended for use in ENT Named without a submission number | |
| * | — | ScalpelTEC, Inc. Myringotomy Safety Scalpel Named without a submission number |
What descends from it? (397)
See all 3977 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991628 | Modified LX-20 CO2 Laser System Family, LX-20SA | 1999 | 377 |
| K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories | 2002 | 376 |
| K063001 | Slim Evolution Family of CO2 Lasers and Delivery Device Accessories | 2007 | 63 |
| K050254 | Spectra-SP CO2 Laser System | 2005 | 13 |
| K091320 | Spectra SP II, Spectra Denta II | 2009 | 12 |
| K082809 | Acupulse 30 and 40 Carbon Dioxide Laser System | 2008 | 12 |
| K970143 | C4 | 1997 | 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?
- Of its descendants, K991628 (Esc Medical Systems, Inc., 1999) has gone furthest, with 377 descendants of its own.
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?
They are intended for soft tissue incision in ENT for the specific indication of Myringotomy/Tympanostomy.
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/K963229 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963229: Sharplan Models 20C, 30C, and 40C CO2 Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963229
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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