510(k) · Cleared
ClearedSIDELAZE800 Laser Beam Delivery Accessory for Cynosure 1440MM Wavelength Lasers
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 Jan 23, 2015 as substantially equivalent to K121127 (Cynosure, Inc., 2012) and 1 other predicate after a 228-day review. Its family tree reaches back 9 generations to 1986.
- Decided
- Jan 23, 2015
- Review
- 228 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K861904 (1986). 31 ancestors in all, the oldest K790187 (1979). No later device cites it as a predicate yet.
- Root · 9 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 5 generations between
- 3 generations backK072870 Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008
- 2 generations backK082819 Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009
- 1 generation backK103014 Miradry SystemMiramar Labs, Inc. · 2011 · Recalled
- This deviceK141511 SIDELAZE800 Laser Beam Delivery Accessory for Cynosure 1440MM…Cynosure, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 8 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
- 7 generations backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 6 generations backK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 5 generations backK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 4 generations backK052919 Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006
- 3 generations backK072870 Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008
- 2 generations backK082819 Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009
- 1 generation backK103014 Miradry SystemMiramar Labs, Inc. · 2011 · Recalled
- This deviceK141511 SIDELAZE800 Laser Beam Delivery Accessory for Cynosure 1440MM…Cynosure, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K861904 | HS-15M Microwave Surgery Equipment, Microtaze | Cooper Lasersonics, Inc. | 1986 | — |
| −8 | K011676 | Vivawave Microwave System | Vivant Medical, Inc. | 2002 | 1 |
| −7 | K023311 | Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −6 | K032047 | Tri-Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −5 | K032702 | Vivatip Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −4 | K052919 | Microsulis Tissue Ablation System | Microsulis Americas, Inc. | 2006 | — |
| −3 | K072870 | Microwave Tissue Coagulation System (MTCS) | Foundry Newco X, Inc. | 2008 | — |
| −2 | K082819 | Dermatologic Treatment System (DTS) G2 | Miramar Labs, Inc. | 2009 | — |
| −1 | K103014 | Miradry System | Miramar Labs, Inc. | 2011 | 2 |
| 0 (this device) | K141511 | SIDELAZE800 Laser Beam Delivery Accessory for Cynosure 1440MM Wavelength Lasers | Cynosure, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 2 | 0 |
| 1986 | 1 | 0 |
| 1994 | 4 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 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 |
|---|---|---|---|
| * | K121127 | Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength LasersSummary page 4…EX-Powered laser surgical instrument, General & Plastic Surgery 21 CFR 878.4810, Class II Premarket Notification: Cynosure Inc, K121127 (05/13/2012) Trade Name: miraDry System Common/usual Name: Microwave And Accessories C… | 2012 |
| * | K103014 | Miradry SystemSummary page 4…ion, Microwave and Accessories, General & Plastic Surgery 21 CFR 878.4400, Class II Premarket Notification: Miramar Labs, Inc., K103014 (01/08/2011) E. Device Description The Cynosure 1440nm Wavelength laser is solid state Nd: YAG laser, having a neodym… | 2011 |
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?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 31 ancestors have a recall of any class.
- 2 other devices also cite its predicate K121127.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
SideLaze800™ is an accessory to deliver optical energy for Cynosure 1440nm wavelength lasers and intended to be used
with Cynosure 1440nm wavelength lasers for surgical incision, excision, vaporization, ablation, and coagulation of soft
tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus,
mucous membrane, lymph vessels and nodes, organs and gland) laser assisted lipolysis and the treatment of primary
axillary hyperhidrosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141511: SIDELAZE800 Laser Beam Delivery Accessory for Cynosure 1440MM Wavelength Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141511
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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