510(k) · Cleared
ClearedSlim Evolution Family of CO2 Lasers and Delivery Device Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lasering S.R.L. · GEX Powered Laser Surgical Instrument
Cleared on Mar 7, 2007 as substantially equivalent to K963339 (Coherent Medical Group, 1997) and 8 other predicates after a 156-day review. Its family tree reaches back 3 generations to 1994. 63 later devices descend from it.
- Decided
- Mar 7, 2007
- Review
- 156 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 3 generations to K936109 (1994). 15 ancestors in all, the oldest K853620 (1986). 63 later devices descend from it, 7 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 deviceK063001 Slim Evolution Family of CO2 Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007
- Descendant · cites it directly · 27 of its ownK091115 ECO2 Laser SystemLutronic Corporation · 2009
- Descendant · cites it directly · 19 of its ownK123573 Youlaser CO2 LaserQuanta System Spa · 2013
- Descendant · cites it directly · 16 of its ownK101555 CO2 Laser SystemAdvanced Technology Laser Co., Ltd. · 2010
- Descendant · 2 generations on · 15 of its ownK110434 Trixel CO2 LaserBeijing Syntech Laser CO., LTD. · 2011
- Descendant · cites it directly · 15 of its ownK080463 Alma Lasers Thermoxel CO2 Laser System and Delivery Device AccessoriesAlma Lasers, Ltd. · 2008
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K091115ECO2 Laser SystemLutronic Corporation · 2009 · cites it directly27descendants
- K123573Youlaser CO2 LaserQuanta System Spa · 2013 · cites it directly19descendants
- K101555CO2 Laser SystemAdvanced Technology Laser Co., Ltd. · 2010 · cites it directly16descendants
- K110434Trixel CO2 LaserBeijing Syntech Laser CO., LTD. · 2011 · 2 generations on15descendants
- K080463Alma Lasers Thermoxel CO2 Laser System and Delivery Device AccessoriesAlma Lasers, Ltd. · 2008 · cites it directly15descendants
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) | K063001 | Slim Evolution Family of CO2 Lasers and Delivery Device Accessories | Lasering S.R.L. | 2007 | — |
| +1 | K091115 | ECO2 Laser System | Lutronic Corporation | 2009 | — |
| +1 | K123573 | Youlaser CO2 Laser | Quanta System Spa | 2013 | — |
| +1 | K101555 | CO2 Laser System | Advanced Technology Laser Co., Ltd. | 2010 | — |
| +2 | K110434 | Trixel CO2 Laser | Beijing Syntech Laser CO., LTD. | 2011 | — |
| +1 | K080463 | Alma Lasers Thermoxel CO2 Laser System and Delivery Device Accessories | Alma Lasers, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 4 | 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? (10)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K062032 | FDA’s K062032 is Accusoft, Accusoft XL Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
| * | K963339 | Coherent Ultrapulse CO2 Surgical LasersSummary page 1…SLIM Evolution Family of C02 Lasers are substantially equivalent the predicate devices Aesculap-Meditec; Multipulse (K0C2032), Coherent Ultrapulse 2500C (K963339) and Lumenis Ltd.(formerly Sharplan Lasers Inc) Model 2CC, 3CC and 40C Surgical Lasers (K963229). The SLIM Evolu… | 1997 |
| * | K963229 | Sharplan Models 20C, 30C, and 40C CO2 LasersSummary page 1…Meditec; Multipulse (K0C2032), Coherent Ultrapulse 2500C (K963339) and Lumenis Ltd.(formerly Sharplan Lasers Inc) Model 2CC, 3CC and 40C Surgical Lasers (K963229). The SLIM Evolution Delivery Device Accessories are substantially equivalent to predicate delivery devices - Sh… | 1996 |
| * | K933918 | Sharplan Model 1080S CO2 Surgical LaserSummary page 1…Delivery Device Accessories are substantially equivalent to predicate delivery devices - Sharplan focused spot handpieces with reusable tip accessories (K933918) - Sharplan fiber/waveguide handpieces (K900076 and K950725) - Sharplan Scanner devices - K955621, K960521 and K9… | 1994 |
| * | K900076 | Sharplan Flexible CO2 Surgical Laser ApplicatorSummary page 1…t to predicate delivery devices - Sharplan focused spot handpieces with reusable tip accessories (K933918) - Sharplan fiber/waveguide handpieces (K900076 and K950725) - Sharplan Scanner devices - K955621, K960521 and K963339) - Sharplan micromaniplutors - (K933918, K881953 a… | 1990 |
| * | K950725 | Sharplan Model 1015 CO2 LaserSummary page 1…predicate delivery devices - Sharplan focused spot handpieces with reusable tip accessories (K933918) - Sharplan fiber/waveguide handpieces (K900076 and K950725) - Sharplan Scanner devices - K955621, K960521 and K963339) - Sharplan micromaniplutors - (K933918, K881953 and K… | 1995 |
| * | K955621 | Sharplan Lasers, Inc Silktouch 2 Flash ScannerSummary page 1…focused spot handpieces with reusable tip accessories (K933918) - Sharplan fiber/waveguide handpieces (K900076 and K950725) - Sharplan Scanner devices - K955621, K960521 and K963339) - Sharplan micromaniplutors - (K933918, K881953 and K95 1204).… | 1996 |
| * | K960521 | Sharplan Lasers, Inc. Silktouch Flash ScannerSummary page 1…spot handpieces with reusable tip accessories (K933918) - Sharplan fiber/waveguide handpieces (K900076 and K950725) - Sharplan Scanner devices - K955621, K960521 and K963339) - Sharplan micromaniplutors - (K933918, K881953 and K95 1204).… | 1996 |
| * | K881953 | Sharplan Models 719/719SR/719SL Colposlad Cos SUSummary page 1…rplan fiber/waveguide handpieces (K900076 and K950725) - Sharplan Scanner devices - K955621, K960521 and K963339) - Sharplan micromaniplutors - (K933918, K881953 and K95 1204). 7-1 4. Device Description: The SLIM Evolu… | 1988 |
| * | K951204 | Sharplan Model 712 Acuspot MicromanipulatorSummary page 1…e handpieces (K900076 and K950725) - Sharplan Scanner devices - K955621, K960521 and K963339) - Sharplan micromaniplutors - (K933918, K881953 and K95 1204). 7-1 4. Device Description: The SLIM Evolution Family of C02 La… | 1995 |
What descends from it? (63)
See all 637 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091115 | ECO2 Laser System | 2009 | 27 |
| K123573 | Youlaser CO2 Laser | 2013 | 19 |
| K101555 | CO2 Laser System | 2010 | 16 |
| K080463 | Alma Lasers Thermoxel CO2 Laser System and Delivery Device Accessories | 2008 | 15 |
| K072182 | Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060 | 2008 | 3 |
| K083918 | Atl CO2 Medical Laser Systems, Models Atl-150 and Atl-250 | 2009 | 0 |
| K072023 | Ellipse Juvia, Model 9EJU7465 | 2007 | 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 13 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K091115 (Lutronic Corporation, 2009) has gone furthest, with 27 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. 2007, 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?
The SLIM Evolution Family of C02 Lasers and delivery device accessories are intended for use in surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. Dermatology, Plastic Surgery and General Surgery procedures including but not limited to - Laser skin resurfacing Treatment of furrows and…
Read the full statement (218 words)
The SLIM Evolution Family of C02 Lasers and delivery device accessories are intended for use in surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Dermatology, Plastic Surgery and General Surgery procedures including but not limited to -
Laser skin resurfacing
Treatment of furrows and wrinkles
Removal of skin tags, actinic keratosis, acne scars, keloids, tattos,
telangiectasia, squamous and basel cell carcinoma, warts and uneven
pigmentation.
Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
Blepharoplasty
Site preparation for hair transplants
Dental procedure including but not limited to -
Periodontal procedures such as - gingivectomy, removal of
hyperplasias,gingivoplasty (incision and excision)
Oral Surgery procedures such as - aphous ulcer excision, frenectomy,
benign/malignant lesion ablation, operculectomy and homeostasis
Podiatry procedures including but not limited to -
Ablation, vaporization and excision of soft tissue lesions such as ingrown nail,
fungal nail, porokeratoma, matrixectomy and verrucae vulgares.
Otorhinolaryngology (ENT) procedures including but not limited to -
Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea
vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps.
Gynecology
Treatment of condyloma acuminata, cervical intraepithelial neoplasia,
leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia.
Laparoscopic treatment endometrial lesions, ablation of endometriosis,
fimbroplasty,
Tubal microsurgery, salpingostomy, histerectomy, uterine myomas and
fibroids
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063001: Slim Evolution Family of CO2 Lasers and Delivery Device Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063001
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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