Manufacturer
Quanta System SpaGuardian 1000
Country / Region:Italy (IT)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
- K151629
- Device name
- Guardian 1000
- Company
- Quanta System Spa
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2015-06-17
- Decision date
- 2015-10-27
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Vascular treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
Guardian 1000 with its delivery accessories is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle. Guardian 1000 with its delivery accessories is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, neurosurgery, general surgery, genitourinary surgery (urology), thoracic surgery, gynecology, pulmonology, ophthalmology, orthopedics, otolaryngology (ENT) and podiatry. Gastroenterology - Hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms; hemostasis in colonoscopy. Neurosurgery - Tumors adjacent to the spinal cord; tumors adjacent to the cortex. General Surgery - Ablation, vaporization, excision, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include but are not limited to: Laparoscopic: appendectomy, cholecystectomy, bowel resection. Open: mastectomy, reduction mammoplasty, breast biopsy, rectal and anal hemorrhoidectomy, bowel resection, colectomy, cholecystectomy, liver resection, condyloma, thyroidectomy, thoracotomy; cavernous hemangioma. Genitourinary (Urology) - Transurethral: transurethral incision of the prostate (TUIP), bladder tumors, bladder neck incisions, urethral strictures, exterior sphincterotomy, laparoscopic lymphadenectomy. Open: condyloma, circumcision, benign and malignant lesions of external genitalia. Thoracic Surgery - Pulmonary resection, coagulation of blebs and bullae, adhesiolysis, pericardiectomy, mediastinal and thoracic lesions and abnormalities, mediastinal lymph node dissection, hemostasis; thoracotomy. Gynecology (GYN) - Laparoscopic excision/lysis of adhesions, endometrial lesions, including ablation of endometriosis, laparoscopic assisted hysterectomy (LAVH), laser uterosacral nerve ablation (LUNA); myomectomy; ovarian cystectomy, ovarian drilling, tubal fimbrioplasty, appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN, condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erithroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/polyps/adhesions; Resection of septum. Pulmonology - Tracheal bronchial lesions. Ophthalmology - Oculoplastics, open DCR, endo-nasal DCR, tumor excision and biopsy, eyelid reconstruction; blepharoplasty. Orthopedics - Dissect and coagulate. Otolaryngology (ENT) - Nasal/Sinus: turbinectomy and turbinate reduction/ablation; polypectomy of nose and nasal passages; ethmoidectomy;
Intended Use
Guardian 1000 with its delivery accessories is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle. Guardian 1000 with its delivery accessories is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, neurosurgery, general surgery, genitourinary surgery (urology), thoracic surgery, gynecology, pulmonology, ophthalmology, orthopedics, otolaryngology (ENT) and podiatry.
Device Description
Guardian 1000 delivers an invisible laser beam in the infrared spectrum at 980 nm using a gallium aluminum arsenide (GaAIAs) source. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers. Guardian 1000 consists of two main sub-systems: a laser console and its delivery accessories, as follows: The laser console includes: - an external enclosure - power electronics - touch screen display with control electronics which controls: o power electronics o user interface o laser source temperature o laser source emission - a laser system including: o laser source o cooling system (Peltier cells, dissipator and fans) o fiber launching system o aiming beam. Laser radiation is delivered to the patient through an optical fiber and several handpieces depending on the treatment. The optical fiber is connected to the laser unit through a SMA905 connector.
Summary parsed at:2026-06-01 06:11:17 UTC
