# K121127: Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers

- Pathway: 510(k) (Special)
- Applicant: Cynosure, Inc.
- Decided: May 13, 2012 after 30 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
Longest line of descent: 2 generations back to K941909 (1994). 8 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091537: Cynosure Smartlipo Multiwavelength Laser with 1440NM Wavelength, Cynosure, Inc. (2009) Summary page 2.
- K102541: Cynosure Cellulaze Laser, Cynosure, Inc. (2012) Summary page 2.
- K112987: Twister Side Fire Optical Fiber Delivery System, Biolitec Medical Devices, Inc. (2011) Summary page 2.

## Most influential descendants
- K124003: Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and Aspirating Laser Probes, Med-Fibe (2013), 23 descendants of its own
- K170366: Laser Peripherals, LLC Family of Bare Laser Fibers (2017), 13 descendants of its own
- K220189: LISA Laser Surgical Fibers (2022), 5 descendants of its own
- K140470: Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission Fiber, Dental Surgery Fiber (2014), 5 descendants of its own
- K131473: (Quanta System) Surgical Laser Fibers (2013), 5 descendants of its own

## Indications for use
SideLaze800 is an accessory to deliver optical energy for Cynosure 1440nm wavelength lasers and intended to be used with Cynosure 1440nm wavelength lasers' cleared indications for use, such as the 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 glands) and laser assisted lipolysis. SideLaze800 may be used in combination with a Cynosure SMA-compatible laser system for the same indications.

Source page: https://510kreport.com/device/K121127
Methodology: https://510kreport.com/methodology