510(k) · Cleared
ClearedCoherent Ultrapulse CO2 Surgical Lasers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coherent Medical Group · GEX Powered Laser Surgical Instrument
Cleared on Jan 22, 1997 as substantially equivalent to K951812 (Lumenis, Inc., 1995) and 5 other predicates after a 149-day review. Its family tree reaches back 2 generations to 1994. 675 later devices descend from it.
- Decided
- Jan 22, 1997
- Review
- 149 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K936109 (1994). 8 ancestors in all, the oldest K853620 (1986). 675 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 1 generation backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- This deviceK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- Descendant · cites it directly · 653 of its ownK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- Descendant · cites it directly · 376 of its ownK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
- Descendant · 2 generations on · 350 of its ownK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- Descendant · 3 generations on · 342 of its ownK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- Descendant · cites it directly · 323 of its ownK030147 Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003
Showing 5 of 675 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 675 · See all- K974789Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998 · cites it directly653descendants
- K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc. · 2002 · cites it directly376descendants
- K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…Lumenis, Inc. · 1999 · 2 generations on350descendants
- K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis · 2001 · 3 generations on342descendants
- K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003 · cites it directly323descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −1 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| 0 (this device) | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| +1 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| +1 | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device… | Lumenis, Inc. | 2002 | — |
| +2 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| +3 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| +1 | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers | Lumenis, Ltd. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 10 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 11 | 0 |
| 2008 | 22 | 0 |
| 2009 | 12 | 0 |
| 2010 | 20 | 0 |
| 2011 | 27 | 0 |
| 2012 | 26 | 0 |
| 2013 | 32 | 0 |
| 2014 | 27 | 0 |
| 2015 | 26 | 0 |
| 2016 | 38 | 0 |
| 2017 | 27 | 0 |
| 2018 | 32 | 0 |
| 2019 | 21 | 0 |
| 2020 | 43 | 0 |
| 2021 | 31 | 0 |
| 2022 | 46 | 0 |
| 2023 | 38 | 0 |
| 2024 | 51 | 0 |
| 2025 | 61 | 0 |
| 2026 | 44 | 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? (6)
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 |
|---|---|---|---|
| * | K951812 | Modified Coherent Ultrapulse CO2 Surgical LasersSummary page 1…ation Name: Laser Powered Surgical Instrument (and Accessories). II1. Predicate Devices ¢ Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and Delivery Accessories (K951812 & K912029) marketed by Coherent Medical Group; ¢ Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE Carbon D… | 1995 |
| * | K912029 | Ultrapulse (TM) Carbon Dioxide Surgical LaserSummary page 1…: Laser Powered Surgical Instrument (and Accessories). II1. Predicate Devices ¢ Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and Delivery Accessories (K951812 & K912029) marketed by Coherent Medical Group; ¢ Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE Carbon Dioxide Sur… | 1991 |
| * | K946304 | Coherent Family of CO2 Surgical Laser Scanner HandpiecesSummary page 1…ssories (K951812 & K912029) marketed by Coherent Medical Group; ¢ Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (K946304) marketed by Coherent Medical Group; . Cohe}z?ent Xanar XA-50 Carbon Dioxide Surgical Laser (K853620) marketed by Coherent/Xanar… | 1995 |
| * | K853620 | Model XA-50 - CO2 Surgical LaserSummary page 1…es for use with Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (K946304) marketed by Coherent Medical Group; . Cohe}z?ent Xanar XA-50 Carbon Dioxide Surgical Laser (K853620) marketed by Coherent/Xanar ¢ Sharplan Carbon Dioxide SilkLaser with FeatherTouch and SilkTouch (510(k) cleared November 4, 1996… | 1986 |
| * | K960521 | Sharplan Lasers, Inc. Silktouch Flash ScannerSummary page 1…ical Laser (K853620) marketed by Coherent/Xanar ¢ Sharplan Carbon Dioxide SilkLaser with FeatherTouch and SilkTouch (510(k) cleared November 4, 1996 - K number unknown, K960521, & K955621) IV. Product Description The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (and its delivery accessories) are i… | 1996 |
| * | K955621 | Sharplan Lasers, Inc Silktouch 2 Flash ScannerSummary page 1…(K853620) marketed by Coherent/Xanar ¢ Sharplan Carbon Dioxide SilkLaser with FeatherTouch and SilkTouch (510(k) cleared November 4, 1996 - K number unknown, K960521, & K955621) IV. Product Description The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (and its delivery accessories) are intended to… | 1996 |
What descends from it? (675)
See all 6759 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | 1998 | 653 |
| K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories | 2002 | 376 |
| K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers | 2003 | 323 |
| K063001 | Slim Evolution Family of CO2 Lasers and Delivery Device Accessories | 2007 | 63 |
| K073111 | Portrait PSR, Model 745915 | 2008 | 4 |
| K072182 | Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060 | 2008 | 3 |
| K020408 | System 2000 Controller, System 5000 Controller, Footswitch, Power Cord, and Visage Wandsff | 2002 | 0 |
| K980398 | Kaplan Pendulaser 115 Surgical Laser with Optoscan II | 1998 | 0 |
| K972915 | Erbium 2000 Laser Family | 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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K974789 (Lumenis, Inc., 1998) has gone furthest, with 653 descendants of its own.
- 8 other devices also cite its predicate K951812.
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?
The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and the Delivery Accessories that are used with them to deliver light energy are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); arthroscopy (knee surgery); and open and endoscopic general…
Read the full statement (407 words)
The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and the Delivery Accessories that are used with them to deliver light energy are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); arthroscopy (knee surgery); and open and endoscopic general surgery.
The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers are safe and effective when indicated for use in specific surgical applications including:
Dermatology & Plastic Surgery
* Ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery (using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces) in the performance of laser skin resurfacing and laser derm-abrasion (using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces), and laser burn debridement.
* Laser skin resurfacing (ablation and/or vaporization) in dermatology and plastic surgery using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces for the treatment of wrinkles, rhytids, and furrows.
* Laser skin resurfacing (ablation and/or vaporization) of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, solar/actinic elastosis, actinic cheilitis, lentinges, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous cell carcinoma, epidermal nevi, xanthelasma palpebrarum, syringoma, and verrucae vulgares (warts).
Dermatology. Plastic Surgery and General Surgery
* Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery for the performance of blepharoplasty.
* Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery for the creation of recipient sites for hair transplantation.
Podiatry
* Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares (warts)
* Laser ablation, vaporization, and/or excision in podiatry for matrixectomy.
Otorhinolaryngology (ENT)
* Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, adult and juvenile papillomatosis polyps, rhinophyma, and verrucae vulgares (warts).
Gynecology
* Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies), and vulvar and vaginal intraepithelial neoplasia
Neurosurgery
* Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.
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/K963339 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963339: Coherent Ultrapulse CO2 Surgical Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963339
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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