# K081181: Smart CO2 (Smart US 20D / Ultraspeed, Smart Clinic and Periopulse) Surgical Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: May 5, 2008 after 10 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Lumenis OpusDent Family laser: named in the summary without a submission number
- (no number) Millennium Dental Technologies PerioLase Dental Laser: named in the summary without a submission number

## Most influential descendants
- K091320: Spectra SP II, Spectra Denta II (2009), 12 descendants of its own
- K132661: Lightscalpel (2014), 3 descendants of its own
- K123494: SOLEA (2013), 3 descendants of its own
- K100610: Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser Systems (2011), 3 descendants of its own
- K141658: Light Scalpel (2014), 2 descendants of its own

## Indications for use
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)

Source page: https://510kreport.com/device/K081181
Methodology: https://510kreport.com/methodology