510(k) · Cleared
ClearedAcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jul 16, 2020 as substantially equivalent to K180597 (Lumenis, Ltd., 2018) after a 27-day review. Its family tree reaches back 9 generations to 1994. 2 later devices descend from it.
- Decided
- Jul 16, 2020
- Review
- 27 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K936109 (1994). 29 ancestors in all, the oldest K822136 (1982). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 5 generations between
- 3 generations backK082809 Acupulse 30 and 40 Carbon Dioxide Laser SystemLumenis, Inc. · 2008
- 2 generations backK100415 Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemLumenis · 2010 · Recalled
- 1 generation backK180597 AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G…Lumenis, Ltd. · 2018
- This deviceK201663 AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK202428 AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK212703 AcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd. · 2021
Show all 9 generations
- Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 8 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 7 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 6 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 5 generations backK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
- 4 generations backK030147 Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003
- 3 generations backK082809 Acupulse 30 and 40 Carbon Dioxide Laser SystemLumenis, Inc. · 2008
- 2 generations backK100415 Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemLumenis · 2010 · Recalled
- 1 generation backK180597 AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G…Lumenis, Ltd. · 2018
- This deviceK201663 AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd. · 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 |
|---|---|---|---|---|---|
| −9 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −8 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −6 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −5 | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device… | Lumenis, Inc. | 2002 | — |
| −4 | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers | Lumenis, Ltd. | 2003 | — |
| −3 | K082809 | Acupulse 30 and 40 Carbon Dioxide Laser System | Lumenis, Inc. | 2008 | — |
| −2 | K100415 | Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser System | Lumenis | 2010 | 1 |
| −1 | K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO | Lumenis, Ltd. | 2018 | — |
| 0 (this device) | K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Lumenis, Ltd. | 2020 | — |
| +1 | K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Lumenis, Ltd. | 2020 | — |
| +1 | K212703 | AcuPulse CO2 Laser System, Delivery Devices and Accessories | Lumenis, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOSummary page 4…Class II Regulation Number: 21 CFR 878.4810 Panel: General & Plastic Surgery Predicate Devices: AcuPulse Family of CO2 Lasers system (K180597) Intended Use/ Indications for Use: Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for inci… | 2018 |
| † | K133895 | Deka Smartxide Laser System | 2014 |
| † | K101555 | CO2 Laser System | 2010 |
| † | K063001 | Slim Evolution Family of CO2 Lasers and Delivery Device Accessories | 2007 |
| † | K160312 | Fraxis Duo | 2016 |
| † | K172096 | Fraxis | 2017 |
| † | K082809 | Acupulse 30 and 40 Carbon Dioxide Laser System | 2008 |
| † | K100415 | Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser System | 2010 |
What descends from it? (2)
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 26 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 29 ancestors has a recall of any class.
- Of its descendants, K202428 (Lumenis, Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K180597.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
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/K201663 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201663: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201663
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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