# K991994: Twilight

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Sep 10, 1999 after 88 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: 2 generations back to K922901 (1992). 7 ancestors in all.
280 later devices descend from it; 3 cite it directly.
0 of 288 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954316: Aurora Surgical Diode Laser System W/Accessories, Premier Laser Systems, Inc. (1995) Summary page 2.
- K972325: Pulsemaster 1000 ST Dental Laser System, American Dental Technologies, Inc. (1997) Summary page 2.
- K974057: Dentek LD 15 Lasersystem, Dentek Lasersystems Produktions Ges.M.B.H. (1998) Summary page 2.
- K981379: Aurora, Premier Laser Systems, Inc. (1998) Summary page 2.
- K961269: Pulsemaster, American Dental Technologies, Inc. (1997) Summary page 2.
- K974586: Aurora Diode Laser System, Premier Laser Systems, Inc. (1998) Summary page 2.

## Most influential descendants
- K012511: Waterlase Millennium (2002), 246 descendants of its own
- K021508: Opusduo EC Dental Laser System (2002), 240 descendants of its own
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own

## 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. Examples: Removal of beningn 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 kyperkeratosis. Excision of carcinoma of the larynx. Laryngeal papillomectomy. Excision and vaporization of herpes simplex I and II. Arthroscopy: Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery. Examples: Menisectomy Synovectomy Chondromalacia Gastroenterology: Hemostasis, incision, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Examples: 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: Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of Keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy General Surgery, Dermatology & Plastic Surgery, and Podiatry (continues): Examples: 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. Examples: Hemorrhoidectomy Excision, vaporization, and hemostasis of rectal pathology Excision, vaporization, and hemostasis of abdominal tumors Gynecology: Ablation, excision, hemostasis and vaporization of tissue. Examples: Endometrial ablation Excision or vaporization of condylomata acuminata Vaporization of CIN (cervical intraepithelial neoplasia) Cervical conization Menorrhagia Neurosurgery: Hemostasis of tissue. Example: Hemostasis in conjunction with meningiomas Ophthalmology: Retinal photocoagulation Diabetic retinopathy Pulmonary Surgery: Hemostasis, vaporization, and excision of tissue. Examples: Tracheobronchial malignancy or stricture Pulmonary Surgery (continues): Hemostasis, vaporization, and excision of tissue. Examples: Benign and malignant pulmonary obstruction Urology: Hemostasis, vaporization and excision of tissues. Examples: Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia.

Source page: https://510kreport.com/device/K991994
Methodology: https://510kreport.com/methodology