510(k) · Cleared
ClearedCoherent Ultrapulse S Series CO2 Surgical Lasers Model C and L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 9, 1998 as substantially equivalent to K963339 (Coherent Medical Group, 1997) and 3 other predicates after a 77-day review. Its family tree reaches back 3 generations to 1994. 653 later devices descend from it.
- Decided
- Mar 9, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K936109 (1994). 9 ancestors in all, the oldest K853620 (1986). 653 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 2 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 1 generation backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- This deviceK974789 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 · cites it directly · 350 of its ownK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- Descendant · 2 generations on · 342 of its ownK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 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
Showing 5 of 653 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 653 · See all- 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 · cites it directly350descendants
- K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis · 2001 · 2 generations on342descendants
- K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003 · 2 generations on323descendants
- K031795Reliant Laser SystemReliant Technologies, Inc. · 2003 · 2 generations on318descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −2 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −1 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| 0 (this device) | 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 | — |
| +1 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| +2 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| +2 | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers | Lumenis, Ltd. | 2003 | — |
| +2 | K031795 | Reliant Laser System | Reliant Technologies, Inc. | 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 |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 9 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 10 | 0 |
| 2008 | 22 | 0 |
| 2009 | 11 | 0 |
| 2010 | 19 | 0 |
| 2011 | 26 | 0 |
| 2012 | 26 | 0 |
| 2013 | 32 | 0 |
| 2014 | 27 | 0 |
| 2015 | 26 | 0 |
| 2016 | 37 | 0 |
| 2017 | 26 | 0 |
| 2018 | 32 | 0 |
| 2019 | 19 | 0 |
| 2020 | 41 | 0 |
| 2021 | 30 | 0 |
| 2022 | 45 | 0 |
| 2023 | 38 | 0 |
| 2024 | 51 | 0 |
| 2025 | 58 | 0 |
| 2026 | 41 | 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? (4)
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 |
|---|---|---|---|
| * | K963339 | Coherent Ultrapulse CO2 Surgical LasersSummary page 1…ification Name: Laser Powered Surgical Instrument (and Accessories) I11. Predicate Devices Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and Delivery Accessories (K963339, K951812 & K912029) marketed by Coherent Medical Group; Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE C… | 1997 |
| * | K951812 | Modified Coherent Ultrapulse CO2 Surgical LasersSummary page 1…Name: Laser Powered Surgical Instrument (and Accessories) I11. Predicate Devices Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and Delivery Accessories (K963339, K951812 & K912029) marketed by Coherent Medical Group; Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE Carbon Dio… | 1995 |
| * | K912029 | Ultrapulse (TM) Carbon Dioxide Surgical LaserSummary page 1…er Powered Surgical Instrument (and Accessories) I11. Predicate Devices Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and Delivery Accessories (K963339, K951812 & K912029) marketed by Coherent Medical Group; Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE Carbon Dioxide Surgi… | 1991 |
| * | K946304 | Coherent Family of CO2 Surgical Laser Scanner HandpiecesSummary page 1…K912029) marketed by Coherent Medical Group; Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (K963339, K951812 and K946304) marketed by Coherent Medical Group. IV. Product Description The Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers (… | 1995 |
What descends from it? (653)
See all 6533 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 4 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K022060 (Lumenis, Inc., 2002) has gone furthest, with 376 descendants of its own.
- 8 other devices also cite its predicate K963339.
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?
Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers (and the delivery accessories that are used with them to deliver laser 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), and open and endoscopic general…
Read the full statement (422 words)
Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers (and the delivery accessories that are used with them to deliver laser 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), and open and endoscopic general surgery.
Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers are indicated for use in the performance of specific surgical applications in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), and open and endoscopic general surgery as follows:
Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- Laser skin resurfacing
- Laser derm-abrasion
- Laser burn debridement.
Dermatology & Plastic Surgery - Continued
Laser skin resurfacing (ablation and/or vaporization) in dermatology and plastic surgery for the treatment of wrinkles, rhytids and furrows.
Clinical study demonstrated that skin resurfacing of wrinkles, rhytids, and furrows with the ULTRAPULSE CO2 surgical laser increases the amount of sub-epidermal collagen.
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
- lentigines
- uneven pigmentation/dyschromia
- acne scars
- surgical scars
- keloids
- hemangiomas (including buccal hemangiomas)
- tattoos
- telangiectasia
- squamous cell carcinoma
- epidermal nevi
- xanthelasma palpebrarum
- syringoma
- verrucae vulgares (warts).
Dermatology, Plastic Surgery & 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 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
- 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)
- 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
- 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/K974789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974789: Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974789
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