# K141511: SIDELAZE800 Laser Beam Delivery Accessory for Cynosure 1440MM Wavelength Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Jan 23, 2015 after 228 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: 9 generations back to K861904 (1986). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121127: Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers, Cynosure, Inc. (2012) Summary page 4.
- K103014: Miradry System, Miramar Labs, Inc. (2011) Summary page 4.

## 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 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.

Source page: https://510kreport.com/device/K141511
Methodology: https://510kreport.com/methodology