Manufacturer
Asclepion Laser Technologies GmbHMULTIPULSE TM+1470
Asclepion Laser Technologies GmbH
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K133891
- Device name
- MULTIPULSE TM+1470
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2013-12-20
- Decision date
- 2015-01-30
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The MultiPulse TM+1470 Laser system and its fibre optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy. Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: - Urethral Strictures - Bladder Neck Incisions (BNI) - Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors - Ablation of Benign Prostatic Hypertrophy (BPH) - Transurethral incision of the prostate (TUIP) - Laser Resection of the Prostate (HoLRP) - Laser Enucleation of the Prostate (HoLEP) - Laser Ablation of the Prostate (HoLAP) - Condylomas - Lesions of external genitalia Gastroenterology Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: - Appendectomy - Polyps - Biopsy - Gall Bladder calculi - Biliary/Bile duct calculi - Ulcers - Gastric ulcers - Duodenal ulcers - Non Bleeding Ulcers - Pancreatitis - Hemorrhoids - Cholecystectomy - Benign and Malignant Neoplasm Angiodysplasia - Colorectal cancer - Telangiectasia - Telangiectasia of the Osler-Weber-Renu disease - Vascular Malformation - Gastritis - Esophagitis - Esophageal ulcers - Varices - Colitis - Mallory-Weiss tear - Gastric Erosions Gynecology Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis): - Intra-uterine treatment of submucous fibroids, benign endometrial polyps and uterine septum by incision, excision, ablation and/or vessel coagulation, - Soft tissue excision procedures such as excisional conization of the cervix ENT Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including: - Endonasal/sinus Surgery - Partial turbinectomy - Polypectomy - Dacryocystorhinostomy - Frontal Sinusotomy - Ethmoidectomy - Maxillary antrostomy - Functional endoscopic sinus surgery - Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal - Tonsillectomy - Adenoidectomy General surgery Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: - Cholecystectomy - Lysis of adhesion - Appendectomy - Biopsy - Skin incision - Tissue dissection - Excision of external tumors and lesions - Complete or partial resection of internal organs, tumors and lesions - Mastectomy - Hepatectomy - Pancreatectomy - Splenectomy - Thyroidectomy - Parathyroidectomy - Herniorrhaphy - Tonsillectomy - Lymphadenectomy - Partial Nephrectomy - Pilonidal Cystectomy - Resection of lipoma - Debridement of Decubitus Ulcer -
Intended Use
The MultiPulse TM+1470 Laser system and its fibre optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.
Device Description
The MultiPulse Tm+1470 laser system and its fiber optic delivery system is a laser Class IV, operating in CW or pulsed mode. The device is a combination of a Thulium:YAG laser that emits a wavelength of 1940 nm and a near infrared diode laser module that emits a wavelength of 1470 nm. The laser power up to 150 Watts is transmitted through different optical fibers. Besides of the optical bench the device consists of a power supply, a water cooling unit and a control electronic. The device is operated by a touch screen and a foot switch.
Summary parsed at:2026-06-01 06:10:01 UTC
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