510(k) · Cleared

Cleared

Deka Smartxide Ultraspeed

K172363510(k) TraditionalCleared Nov 17, 2017105-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

El.En Electronic Engineering Spa · GEX Powered Laser Surgical Instrument

Cleared on Nov 17, 2017 as substantially equivalent to K081181 (Cynosure, Inc., 2008) after a 105-day review. Its family tree reaches back 1 generation to 2008.

Decided: Nov 17, 2017
Review: 105 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K081181 (2008). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK081181 Smart CO2 (Smart US 20D / Ultraspeed, Smart Clinic and Periopulse)…Cynosure, Inc. · 2008
This deviceK172363 Deka Smartxide UltraspeedEl.En Electronic Engineering Spa · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K081181	Smart CO2 (Smart US 20D / Ultraspeed, Smart Clinic and Periopulse) Surgical…	Cynosure, Inc.	2008	—
0 (this device)	K172363	Deka Smartxide Ultraspeed	El.En Electronic Engineering Spa	2017	—

FIG. 1 — Lineage of K172363, 2008–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K081181	Smart CO2 (Smart US 20D / Ultraspeed, Smart Clinic and Periopulse) Surgical Laser Summary page 4 …in General and Plastic Surgery and in Dermatology (GEX) Classification Number: 21 CFR 878.4810 Equivalent Devices: DEKA Smart US 20D/UltraSpeed and Smart Clinic laser (K081181). Device Description: DEKA SmartXide UltraSpeed is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source d…	Cynosure, Inc.	2008	—

Also cleared against K081181: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.
1 other device also cites its predicate K081181.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)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 SmartXide UltraSpeed laser is indicated for 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/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic urgery, and urology for surgical and…

Read the full statement (143 words)

Also, the SmartXide UltraSpeed 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).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K172363 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172363: Deka Smartxide Ultraspeed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172363

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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