510(k) · Cleared
ClearedSmartlipo ND:Yag 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 Oct 31, 2006 after an 83-day review. The FDA summary names its predicate without a number. 182 later devices descend from it.
- Decided
- Oct 31, 2006
- Review
- 83 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
182 later devices descend from it, 8 citing it directly.
- This deviceK062321 Smartlipo ND:Yag LaserCynosure, Inc. · 2006
- Descendant · cites it directly · 153 of its ownK072779 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- Descendant · cites it directly · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- Descendant · cites it directly · 125 of its ownK072751 Cooltouch Models NS 160 and LC215 CoolipoNew Star Lasers, Inc. · 2008
- Descendant · 2 generations on · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
- Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Showing 5 of 182 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 182 · See all- K072779Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008 · cites it directly153descendants
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · cites it directly129descendants
- K072751Cooltouch Models NS 160 and LC215 CoolipoNew Star Lasers, Inc. · 2008 · cites it directly125descendants
- K081352Profile Multi-Platform SystemSciton, Inc · 2008 · 2 generations on112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062321 | Smartlipo ND:Yag Laser | Cynosure, Inc. | 2006 | — |
| +1 | K072779 | Ceralas D 980NM Diode Laser, Models D15 and D25 | Biolitec, Inc. | 2008 | — |
| +1 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| +1 | K072751 | Cooltouch Models NS 160 and LC215 Coolipo | New Star Lasers, Inc. | 2008 | — |
| +2 | K081352 | Profile Multi-Platform System | Sciton, Inc | 2008 | — |
| +2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 14 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 8 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 9 | 0 |
| 2019 | 8 | 0 |
| 2020 | 12 | 0 |
| 2021 | 11 | 0 |
| 2022 | 18 | 0 |
| 2023 | 12 | 0 |
| 2024 | 16 | 0 |
| 2025 | 18 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | — | Laserscope Lyra Series Nd:YAG Laser system Named without a submission number |
What descends from it? (182)
See all 1828 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072779 | Ceralas D 980NM Diode Laser, Models D15 and D25 | 2008 | 153 |
| K070388 | Profile Multi-Platform System | 2007 | 129 |
| K072751 | Cooltouch Models NS 160 and LC215 Coolipo | 2008 | 125 |
| K073715 | ELIPO | 2008 | 81 |
| K090126 | Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model… | 2009 | 80 |
| K073617 | Pharaon Lipo | 2008 | 17 |
| K080567 | Palomar Aspire Laser Platform | 2008 | 10 |
| K082721 | Laserpro 810, 940 and 980 Diode Laser Systems | 2008 | 7 |
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, K072779 (Biolitec, Inc., 2008) has gone furthest, with 153 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.
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 SmartLipo Laser is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The SmartLipo is further indicated for laser assisted lipolysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062321: Smartlipo ND:Yag Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062321
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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