510(k) · Cleared
ClearedCO2 Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Technology Laser Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Sep 17, 2010 as substantially equivalent to K063001 (Lasering S.R.L., 2007) after a 105-day review. Its family tree reaches back 4 generations to 1994. 16 later devices descend from it.
- Decided
- Sep 17, 2010
- Review
- 105 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K936109 (1994). 16 ancestors in all, the oldest K853620 (1986). 16 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 3 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 2 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 1 generation backK063001 Slim Evolution Family of CO2 Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007
- This deviceK101555 CO2 Laser SystemAdvanced Technology Laser Co., Ltd. · 2010
- Descendant · cites it directly · 15 of its ownK110434 Trixel CO2 LaserBeijing Syntech Laser CO., LTD. · 2011
- Descendant · 2 generations on · 14 of its ownK161925 CO2 Laser Therapy MachineBeijing Adss Development Co., Ltd. · 2016
- Descendant · 3 generations on · 8 of its ownK192528 CO2 Laser Therapy SystemShangdong Huamei Technology Co., Ltd. · 2019
- Descendant · 4 generations on · 5 of its ownK200042 CO2 Laser SystemBeijing Superlaser Technology Co., Ltd. · 2020
- Descendant · 3 generations on · 2 of its ownK162398 CO2 Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co. · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K110434Trixel CO2 LaserBeijing Syntech Laser CO., LTD. · 2011 · cites it directly15descendants
- K161925CO2 Laser Therapy MachineBeijing Adss Development Co., Ltd. · 2016 · 2 generations on14descendants
- K192528CO2 Laser Therapy SystemShangdong Huamei Technology Co., Ltd. · 2019 · 3 generations on8descendants
- K200042CO2 Laser SystemBeijing Superlaser Technology Co., Ltd. · 2020 · 4 generations on5descendants
- K162398CO2 Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co. · 2017 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −3 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −2 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −1 | K063001 | Slim Evolution Family of CO2 Lasers and Delivery Device Accessories | Lasering S.R.L. | 2007 | — |
| 0 (this device) | K101555 | CO2 Laser System | Advanced Technology Laser Co., Ltd. | 2010 | — |
| +1 | K110434 | Trixel CO2 Laser | Beijing Syntech Laser CO., LTD. | 2011 | — |
| +2 | K161925 | CO2 Laser Therapy Machine | Beijing Adss Development Co., Ltd. | 2016 | — |
| +3 | K192528 | CO2 Laser Therapy System | Shangdong Huamei Technology Co., Ltd. | 2019 | — |
| +4 | K200042 | CO2 Laser System | Beijing Superlaser Technology Co., Ltd. | 2020 | — |
| +3 | K162398 | CO2 Laser Therapy Systems | Beijing Sincoheren Science and Technology Development Co. | 2017 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K063001 | Slim Evolution Family of CO2 Lasers and Delivery Device AccessoriesSummary page 2…R 878.481 0 Product Code: GEX Panel: 878 General and Plastic Surgery 5. Predicate. Device SLIM Evolution Family Of CO 2 Laser and Delivery Device Accessories (K063001) 6. Device Description eBearn CO 2 Laser System is an intelligent sealed-off CO2 laser. c~eam CO 2 Laser System delivers… | 2007 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110434 | Trixel CO2 Laser | 2011 | 15 |
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 16 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K110434 (Beijing Syntech Laser CO., LTD., 2011) has gone furthest, with 15 descendants of its own.
- 6 other devices also cite its predicate K063001.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
eBeam CO 2 Laser System are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (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 fin-rows and wrinkles…
Read the full statement (223 words)
eBeam CO 2 Laser System are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (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 fin-rows and wrinkles
Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, 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, verrucae vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps.
Gynecology
Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia.
This device is for prescription use only.
The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101555: CO2 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101555
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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