510(k) · Cleared
ClearedModified LX-20 CO2 Laser System Family, LX-20SA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esc Medical Systems, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Aug 9, 1999 as substantially equivalent to K960475 (Luxar Corp., 1996) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1995. 377 later devices descend from it.
- Decided
- Aug 9, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K953074 (1995). 4 ancestors in all, the oldest K935563 (1994). 377 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK953074 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1995
- 1 generation backK960475 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1996
- This deviceK991628 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
- Descendant · 2 generations on · 284 of its ownK042319 Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005
Showing 5 of 377 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 377 · See all- 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
- K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005 · 2 generations on284descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953074 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1995 | — |
| −1 | K960475 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1996 | — |
| 0 (this device) | 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 | — |
| +2 | K042319 | Reliant Laser II System and Accessories | Reliant Technologies, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 9 | 0 |
| 2008 | 13 | 0 |
| 2009 | 7 | 0 |
| 2010 | 7 | 0 |
| 2011 | 13 | 0 |
| 2012 | 8 | 0 |
| 2013 | 11 | 0 |
| 2014 | 12 | 0 |
| 2015 | 12 | 0 |
| 2016 | 13 | 0 |
| 2017 | 12 | 0 |
| 2018 | 22 | 0 |
| 2019 | 10 | 0 |
| 2020 | 28 | 0 |
| 2021 | 19 | 0 |
| 2022 | 36 | 0 |
| 2023 | 25 | 0 |
| 2024 | 41 | 0 |
| 2025 | 41 | 0 |
| 2026 | 26 | 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? (3)
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 |
|---|---|---|---|
| * | K960475 | Modified Luxar LX-20 Family CO2 Laser SystemSummary page 1…rbon dioxide laser 21C.F.R. § 884.4550 Gynecologic surgical laser Legally marketed predicate device used for equivalency: Luxar LX-20 C0, Surgical Laser System Family (K960475) and Sharplan 20C CO0, Laser (K963229 and K935563). Description: The Luxar modified LX-20 Surgical Laser System produces laser… | 1996 |
| * | K963229 | Sharplan Models 20C, 30C, and 40C CO2 LasersSummary page 1…Gynecologic surgical laser Legally marketed predicate device used for equivalency: Luxar LX-20 C0, Surgical Laser System Family (K960475) and Sharplan 20C CO0, Laser (K963229 and K935563). Description: The Luxar modified LX-20 Surgical Laser System produces laser (infrared) energy at a wavelength of 1… | 1996 |
| * | K935563 | Sharplan Surgical CO2 Lasers and AccessoriesSummary page 1…surgical laser Legally marketed predicate device used for equivalency: Luxar LX-20 C0, Surgical Laser System Family (K960475) and Sharplan 20C CO0, Laser (K963229 and K935563). Description: The Luxar modified LX-20 Surgical Laser System produces laser (infrared) energy at a wavelength of 10.6 microns… | 1994 |
What descends from it? (377)
See all 3772 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 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K022060 (Lumenis, Inc., 2002) has gone furthest, with 376 descendants of its own.
- 7 other devices also cite its predicate K960475.
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?
Representative examples: Tattoo removal; port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; keloid reduction; wart removal; basal & squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas, hemangiomas, nevi, and tricoepitheliomas; dermabrasion such as for lentigos, keratoses, actinic keratosis & cheilitis. Representative examples: Gingivectomy; frenum release; removal of soft tissue, cysts…
Read the full statement (309 words)
Representative examples: Tattoo removal; port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; keloid reduction; wart removal; basal & squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas, hemangiomas, nevi, and tricoepitheliomas; dermabrasion such as for lentigos, keratoses, actinic keratosis & cheilitis.
Representative examples: Gingivectomy; frenum release; removal of soft tissue, cysts, and tumors.
Representative examples: Menisectomy; chondromalacia ablation; partial synovectomy, lateral release; PMMA removal.
Representative examples: Hemorrhoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of decubitus ulcers and statis ulcers; mastectomy, breast biopsy, reduction mammoplasty; cytoreduction for metastatic disease; many dermatological procedures.
Representative examples: Subglottic stenosis vaporization; tonsillectomy; removal of vocal cord papillomas, nodules, and polyps; lymphangioma removal; pulmonary bronchial and tracheal lesion removal; turbinectomy; removal of leukoplakia of larynx; ablation of choanal atresia. Myringotomy/tympanostomy; Laser Assisted Uvulopalatoplasty (LAUP).
Representative examples: Plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neruoma removal; ingrown nail treatment.
Intended Use
The modified LX-20 Laser System Family is a general surgical instrument used to vaporize, incise, excise, ablate, or photo coagulate soft tissue in surgical procedures in the listed surgical specialties.
The system may be effectively utilized for those applications recognized as within the accepted indications for use of CO₂ laser devices performed within the listed specialties and which require power densities as calculated by power and spot size referenced in the power density charts in the operator's manual.
Representative examples: Condyloma, excision and vaporization, cervical, vulvar, & perineal; vaginal intraepithelial neoplasia ablation (VAIN); vulvar intraepithelial neoplasia ablation (VIN); herpes vaporization; urethral caruncle vaporization; I&D Bartholin's & nubothian cysts.
Vaporization, incision, excision, ablation, or photo coagulation of soft tissue in endoscopic and laparoscopic surgery including GYN laparoscopy where delivery of energy by the hollow fiber may be more convenient than delivery of energy by a handpiece. Representative examples: endometriosis ablation; excision of adhesions; salpingotomy; metroplasty.
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/K991628 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991628: Modified LX-20 CO2 Laser System Family, LX-20SA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991628
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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