510(k) · Cleared
ClearedSmart CO2 (Smart US 20D / Ultraspeed, Smart Clinic and Periopulse) Surgical Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cynosure, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 5, 2008 after a 10-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- May 5, 2008
- Review
- 10 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK081181 Smart CO2 (Smart US 20D / Ultraspeed, Smart Clinic and Periopulse)…Cynosure, Inc. · 2008
- Descendant · cites it directly · 12 of its ownK091320 Spectra SP II, Spectra Denta IILutronic Corporation · 2009
- Descendant · 2 generations on · 3 of its ownK132661 LightscalpelLightscalpel, LLC · 2014
- Descendant · 2 generations on · 3 of its ownK123494 SOLEAConvergent Dental, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 3 of its ownK100610 Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser…Lutronic Corporation · 2011
- Descendant · 3 generations on · 2 of its ownK141658 Light ScalpelLightscalpel, LLC · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K091320Spectra SP II, Spectra Denta IILutronic Corporation · 2009 · cites it directly12descendants
- K132661LightscalpelLightscalpel, LLC · 2014 · 2 generations on3descendants
- K123494SOLEAConvergent Dental, Inc. · 2013 · 2 generations on3descendants
- K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation · 2011 · 2 generations on3descendants
- K141658Light ScalpelLightscalpel, LLC · 2014 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081181 | Smart CO2 (Smart US 20D / Ultraspeed, Smart Clinic and Periopulse) Surgical… | Cynosure, Inc. | 2008 | — |
| +1 | K091320 | Spectra SP II, Spectra Denta II | Lutronic Corporation | 2009 | — |
| +2 | K132661 | Lightscalpel | Lightscalpel, LLC | 2014 | — |
| +2 | K123494 | SOLEA | Convergent Dental, Inc. | 2013 | 1 |
| +2 | K100610 | Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser Systems | Lutronic Corporation | 2011 | — |
| +3 | K141658 | Light Scalpel | Lightscalpel, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | — | Lumenis OpusDent Family laser Named without a submission number | |
| * | — | Millennium Dental Technologies PerioLase Dental Laser Named without a submission number |
What descends from it? (14)
See all 142 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?
- Of its descendants, K091320 (Lutronic Corporation, 2009) has gone furthest, with 12 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Smart US 20 D / UltraSpeed and Smart Clinic laser is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and…
Read the full statement (182 words)
The Smart US 20 D / UltraSpeed and Smart Clinic laser is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.
Also, the Smart C02 surgical laser is indicated for periodontal applications such as, but not limited to:
Removal of diseased or Inflamed soft tissue in the periodontal pocket (sulcular debridement)
Biopsies
Frenectomy, Frenum release
Gingivoplasty
Papillectomy
Vestibuloplasty
Hyperplasia
Operculectomy
Drainage (abscess)
Flap surgery
Fibroma (nonmalignant tumor, mucosa, tongue)
Epulis
Aphthous ulcers
Removal of soft tissue, cysts, and tumors
Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
The PerioPulselaser is indicated for the removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement). It is also indicated for laser assisted new attachment procedure (cementum-mediated periodontal ligment new attachment to the root surface in the absence of long junctional epithelium)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081181: Smart CO2 (Smart US 20D / Ultraspeed, Smart Clinic and Periopulse) Surgical Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081181
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