Quanta System Surgical Laser fibers

Quanta System Spa

Country / region:Italy (IT)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

2

Device details

FDA 510(k) registration fields

K number
K160513
Device name
Quanta System Surgical Laser fibers
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-02-24
Decision date
2016-03-18
Submission type
Special
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

Quanta System Surgical Laser Fibers are intended to be used in conjunction with any cleared surgical laser manufactured by Quanta System equipped with SMA 905 or SMA 906 or compatible connector. Quanta System Surgical Laser Fibers are indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non-contact mode (with a compatible laser marketed for use in the desired application).  
Quanta System Surgical Laser Fibers (surgical fiber optic laser delivery devices) are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application. 
Quanta System Surgical Laser Fibers are also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated with an approved compatible laser marketed for use in the desired application. 
Quanta System Surgical Laser Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue with an approved compatible laser marketed for use in the desired application. 
Quanta System Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application. 
Quanta System Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode. 
Quanta System Surgical Laser Fibers are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho:YAG, Nd:YAG, Tm:YAG pulsed and continuous wave CW laser devices. 
Quanta System Surgical Laser Fibers may be used in surgical specialty or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, contraindications, precautions and warnings when using fiber optic it is necessary to refer to the applicable laser device User Manual.

Intended Use

Quanta System Surgical Laser Fibers are intended to be used in conjunction with any cleared surgical laser manufactured by Quanta System equipped with SMA 905 or SMA 906 or compatible connector. Quanta System Surgical Laser Fibers are indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non-contact mode (with a compatible laser marketed for use in the desired application). Quanta System Surgical Laser Fibers (surgical fiber optic laser delivery devices) are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application. Quanta System Surgical Laser Fibers are also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated with an approved compatible laser marketed for use in the desired application. Quanta System Surgical Laser Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue with an approved compatible laser marketed for use in the desired application. Quanta System Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application. Quanta System Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode.

Device Description

The Quanta System Surgical Laser Fibers are a Fiber Optic Laser Delivery System meaning a device intended for the delivery of laser radiation to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The Quanta System Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber jacketed with ethylene tetrafluoroethylene (ETFE). The devices are 3.0 meters (9.8 ft) in length and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations and various core diameter sizes (150, 200, 272, 365, 400, 550, 600, 800 and 1000 microns) are offered.

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

Predicate devices

1

K160513 references 1 predicate/reference device

Cited as predicate

2

2 submissions cite K160513 as a predicate