# K130465: EPIC 10S

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Apr 11, 2013 after 45 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: 19 generations back to K943450 (1995). 382 ancestors in all.
No later device cites it as a predicate yet.
0 of 383 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121327: Diolase 10S, Biolase Technology, Inc. (2013) Summary page 4.

## Indications for use
The Epic 10S is intended for use as a laser surgical instrument in general and plastic surgery and in dermatology. It is indicated for the following expanded Indications for Use: Ear, Nose and Throat and Oral Surgery: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity such as: * Removal of benign lesions from ear, nose and throat * Excision and vaporization of vocal cord nodules and polyps * Incision and excision of carcinoma in-situ * Ablation and vaporization of hyperkeratosis * Laryngeal papillectomy * Excision and vaporization of herpes simplex I and II * Neck dissection Arthroscopy: Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery, such as: * Menisectomy * Syovectomy * Chondromalacia Gastroenterology: Hemostasis, incision, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy, such as: * Hemostasis of upper and lower GI bleeding * Excision and vaporization of colorectal carcinoma * Excision of polyps * Hemostasis of colonoscopy * Hemostasis of esophageal varices Orthopedics: * Dissect and coagulate General Surgery, Dermatology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion, such as: * Matrixectomy * Excision of neuromas * Excision of periungual and subungual warts * Excision of plantar warts * Excision of Keloids * Excision of cutaneous lesions * Hemorrhoidectomy * Appendectomy * Debridement of decubitus ulcer * Hepatobiliary * Mastectomy * Dermabrasion * Vaporization & hemostasis of capillary hemangioma * Excision, vaporization & hemostasis of abdominal tumors * Excision, vaporization & hemostasis of rectal pathology * Pilonidal cystectomy * Herniorraphy * Adhesiolysis * Parathyroidectomy * Laparoscopic cholecystecomy * Thyroidectomy * Resection of organs GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues, such as: * Hemorrhoidectomy * Excision, vaporization, and hemostasis of rectal pathology * Excision, vaporization, and hemostasis of abdominal tumors Gynecology: Ablation, excision, hemostasis, and vaporization of tissue, such as: * Excision or vaporization of condylomata acuminata * Vaporization of CIN (cervical intraepithelial neoplasia) * Cervical conization * Menorrhagia * Ovarian cystectomy Neurosurgery: Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue, such as: * Hemostasis in conjunction with meningiomas * Percutaneous Disc Decompression (PLDD) Ophthalmology: * Dacryocystorhinostomy transcanalicular * Open DCR * Tumor Excision * Blepharoplasty Pulmonary Surgery: Hemostasis, vaporization, and excision of tissue, such as: * Tracheobronchial malignancy or stricture * Benign and malignant pulmonary obstruction Cardiac Surgery: * Coagulation and hemostasis of cardiac tissue Thoracic Surgery: * Thoracotomy * Pulmonary resection * Hemostasis * Pericardiectomy * Adhesiolysis * Coagulation of blebs and bullae Urology: Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues, such as: * Vaporization of urethral tumors * Release of urethral stricture * Removal of bladder neck obstruction * Excision and vaporization of condyloma * Lesions of external genitalia * Circumcision * Vaporization of the prostate to treat benign prostate hyperplasia (BPH) Dermatology/Aesthetics: * Photocoagulation of vascular & dermatological lesions of the face and extremities * Photocoagulation of telangiectasia, venulectasia of the legs and face * Treatment of reticular veins and branch varicosities * Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas * Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines, epidermal nevi, spider nevi * Dermatological surgery: Condyloma acuminate, warts, small non-malignant skin tumors, small semi-malignant tumors as basaliomas, Bowe and Kaposi sarcoma, warty leucoplasty and ulcers debridement * Seborrheic keratosis * Mixoid cyst * Papillary varix * Acne treatment Vascular Surgery: * Photocoagulation of vascular & dermatological lesions of the face and extremities * Photocoagulation of telangiectasia, veinulectasia of the legs and face * Treatment of reticular veins and branch varicosities

Source page: https://510kreport.com/device/K130465
Methodology: https://510kreport.com/methodology