SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS

Cynosure, LLC

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K141511
Device name
SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2014-06-09
Decision date
2015-01-23
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cuttingBody contouringVascular treatment
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

SideLaze800™ is an accessory to deliver optical energy for Cynosure 1440nm wavelength lasers and is 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. The miraDry System is indicated for use in the treatment of primary axillary hyperhidrosis. Delivers focused laser energy for surgical incision, excision, vaporization, ablation, and coagulation of soft tissue, which includes ablation of sweat glands. The SideLaze800™ Laser Beam Delivery Accessory targets the sweat glands in the underarm area and uses focused laser energy to ablate their function.

Intended 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.

Device Description

SideLaze800™ Laser Beam Delivery Accessory is an optional side-firing fiber optic accessory used with the Cynosure Lasers with 1440nm wavelength. The SideLaze800™ option is intended to offer physicians a convenient accessory.

Summary parsed at:2026-06-01 06:10:05 UTC

Predicate devices

2

K141511 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K141511 as a predicate