Manufacturer
Cynosure, LLCSIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
- Company
- Cynosure, LLC
- 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
