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

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Device details

FDA 510(k) registration fields

K number
K180158
Device name
Surgical Laser fibers
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2018-01-19
Decision date
2018-02-14
Submission type
Special
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

Surgical Laser Fibers are intended to be used in conjunction with cleared surgical lasers equipped with SMA 905 or SMA 906 or compatible connector. Surgical Laser Fibers are indicated for use in general surgical applications for: incision, excision, vaporization, ablation, haemostasis or coagulation of soft tissue in a contact or non-contact mode (with a compatible laser marketed for use in the desired application). 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. 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. 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. Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application. 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. 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. 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

Surgical Laser Fibers are intended to be used in conjunction with cleared surgical lasers equipped with SMA 905 or SMA 906 or compatible connector. Surgical Laser Fibers are indicated for use in general surgical applications for: incision, excision, vaporization, ablation, haemostasis or coagulation of soft tissue in a contact or non-contact mode (with a compatible laser marketed for use in the desired application). 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. 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. 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. Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application. 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. 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.

Summary parsed at:2026-06-01 05:56:52 UTC

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