# K151629: Guardian 1000

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Oct 27, 2015 after 132 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K943450 (1995). 211 ancestors in all.
No later device cites it as a predicate yet.
0 of 212 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110375: Blueshine's Gold Series, Blueshine Srl (2012) Summary page 5.
- K101893: Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus Biowave 30W Pro IR Lamp System, Nexus, Usa Laser Biotech, Inc. (2011) Summary page 5.

## 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; meatal antrostomy; Laryngo-tracheal: removal of vocal cord/ fold nodules, polyps and cysts; arytenoidectomy; tracheal stenosis; Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; hemi glossectomy; Head & Neck: tumor resection on oral, sub facial and neck tissues; parathyroidectomy; thyroidectomy. Podiatry Matrixectomy, Periungual and subungual warts, Plantar warts, Neuromas. Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and /or yeasts Candida albicans, etc.).

Source page: https://510kreport.com/device/K151629
Methodology: https://510kreport.com/methodology