# K120231: Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec Medical Devices, Inc.
- Decided: Apr 24, 2012 after 90 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). 335 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 340 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112013: Evolve (R) HPD 980/1470NM Multiwavelength Diode Laser, Biolitec, Inc. (2012)

## Most influential descendants
- K133891: Multipulse TM+1470 (2015), 3 descendants of its own
- K253100: MultiPulse TFL (2025), 1 descendant of its own
- K261738: Medical Thulium Fiber Laser Systems (UroFiber 150Q) (2026), 0 descendants of its own
- K202041: Opera Evo (2020), 0 descendants of its own

## Indications for use
The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Evolve HPD Multiwavelength 980/ 1470 Diode Laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (Peripheral nervous systemn), pulmonary surgery, cardiothoracic surgery, dental appilications, and endovenous occlusion of the saphenous veins in patients with superficial vein reflux. The Multiwavelength laser is further indicated for laser assisted lipolysis. The device is specifically indicated for use as follows: Ear, Nose and Throat and Oral Surgery (Otolaryngology) Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include: Removal of benign lesions from the 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 Excision of carcinoma of the larynx Laryngeal papillomectomy Excision and vaporization of herpes simplex I and II Neck dissection Artbroscopy Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during artliroscopic surgery. Examples includey~/( i Menisectomy (6W'~ / UAC X '-- Synovectomy (Division Sigrf-O$f Chondromalacia Division of Surgical, Orthopedic, and Restorative Devices 510(k) Numiber- KI LQ 273I Gastroenterology Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include: Hemostasis of upper and lower GI bleeding Excision and vaporization of colorectal carcinoma Excision of polyps 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. Examples include: Matrixectomy Excision of neuromas Excision of periungual and subungual waits Excision of plantar warts Excision of keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement ofdecubitus ulcers Hepatobiliary tumors Mastectomy Dermabrasion Laser Assisted Lipolysis Vaporization and hemostasis of capillary hemangioma Excision, vaporization and hemostasis of abdominal tumors Excision, vaporization and hemostasis of rectal patholo~ 4 ~, Pildnidal cystectomy (Division Sign-Off Herniorapphy Division of Surgical, Orthopedic, Adhesiolysis and Restorative Devices Parathyroidectomy Laparoscopic cholecystectomy Thyroidectomy 5 10(k) Number K 1-,t Resection of organs Debridement of wounds Photocoagulation of teleangectasia of the legs and face Photocoagulation of vascular lesions of the face and extremities Endovenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities Treatment of reticular veins and branch varicosities Urology Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include: Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia Vaporization of the prostate to treat benign prostatic hyperplasia (BPI-). Note: powers from 15 1W to 200W should only be applied in the vaporizatioin of the prostate to treat Benign Prostatic Hyperplasia (BPH). Gynecology Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include: Endometrial ablation Excision or vaporization of condylomata acumninate Vaporization of cervical intraepithelial neoplasia Cervical conization Menorrhagia Neurosurgery Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas Cardiac Surgery Hemostasis and coagulation of soft tissue, including cardiac tissue. Pulmonary Surgery Hemostasis, vaporization, coagulation, incision, excision and ablati n of soft tissue in the pulmonary system. $%n ,yaj/& f Examples include: (Division Signot Tracheobronchial malignancy or stricture Division of Surgical, Orthopedic, Benign and malignant pulmonary obstruction and Restorative Devices Endoscopic pulmonary applications. Dental Applications 510(k) Number_1_2_0_-_- ___ Indicated for the following applications on mntradral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, opercfilectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/ partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers .and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root banal therapy and light activation of bleaching Materials for teeth whitening. Powers from 151W to 200W Powers from 15 1W to 200W should only be applied in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH).

Source page: https://510kreport.com/device/K120231
Methodology: https://510kreport.com/methodology