# K990903: Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration)

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Aug 27, 1999 after 162 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
No predicates in its family tree.
761 later devices descend from it; 13 cite it directly.
0 of 762 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K770723: Table, Treatment, Therapy, Physical, Chattanooga Pharmacal Co. (1977). Our OCR of the scanned summary read K770723, FDA’s number for Table, Treatment, Therapy, Physical (Chattanooga Pharmacal Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Laserscope ORION Surgical Laser System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K014040: Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models (2002), 739 descendants of its own
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own
- K022923: Candela Gentle Yag Laser System (2003), 656 descendants of its own
- K023193: Candela Gentle Yag Laser System (2002), 656 descendants of its own
- K033172: Candela Gentleyag Family of Laser Systems (2003), 654 descendants of its own

## Indications for use
The LYRA Series Surgical Laser System and Accessories are intended for the surgical incision/excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. KTP/532 Applications Dermatology: Photocoagulation of cutaneous lesions including but not limited to the following general categories of lesions: Vascular lesions (Angiomas, Hemangiomas, Telangiectasia); Benign pigmented lesions (Nevi, Lentigines, Chloasma, Café-au-lait, Tattoos (including but not limited to blue and black dark tattoo ink); Verrucae; Skin Tags; Keratoses; Plaques; Cutaneous Lesion Treatment (Hemostasis, Color Lightening, Blanching, Flattening, Reduction of lesion size). General Surgery: Vaporizing, Coagulating, Incising, Excising, Debulking, and Ablating of Soft tissue as well as in Endoscopic (e.g. laparoscopic) or open surgeries. Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; Gastrointestinal hemostasis (including Varices, Espohagitis, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal Ulcers, Non-bleeding Ulcers, Gastric erosions); Gastrointestinal Tissue ablation (Benign and Malignant neoplasm, Angiodysplasia, Polyps, Ulcer, Colitis, Hemorrhoids). Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: Endometriosis; Cervical, vulvar, and vaginal intraepithelial neoplasia; Condyloma Acuminata; Uterine Septum; Intrauterine adhesions; Submucosal fibroids. Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis. Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type. Opthamology: Post-vitrectomy endophotocoagulation of the retina. Plastic Surgery: Vaparizing, Coagulating, Incising, Excising, debulking, and ablating of soft tissue in endoscapic and open procedures. Spinal Surgery: Percutaneous lumbar diskectomy. Thoracic Surgery: Vaporizing, Coagulating, Incising, Excising, Debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures. Urology: Cutting, coagulating, or vaporizing urologic soft tissues. ND:YAG/1064 Applications Dermatology: Photocoagulation of pigmented lesions to reduce lesion size. For patients with lesions that would potentially benefit from aggressive treatment. For patients with lesions that have not responded to other laser treatments. Endoscopic/Laparoscopic General Surgery: Cutting, ablation, and/or hemostasis of soft tissue in endoscopic or laparoscopic general surgery applications, including but not limited to: Cholecystectomy, Appendectomy, Vagotomy, Pyloromyotomy. Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions including Squamous cell carcinoma and Adenocarcinoma; Gastrointestinal hemostasis including: Varices, Espohagitis, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal uicers, non-bleeding ulcers, Gastric erosions; Gastrointestinal tissue ablation including: Benign and malignant neoplasm; Angiodysplasia; Polyps; Uicer; Colitis; Hemorrhoids. General Surgery: Soft tissue general surgery applications: Skin incision; Tissue dissection; Excision of extemnal tumors and lesions; compiete or partial resection of internal organs, tumors, lesions; Tissue ablation; Vessel Coagulation. Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus; Ablation of endometrial implants and/or peritoneal adhesions; Soft tissue excisional procedures, such as excisional conization of the cervix; intra-uterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated including Submucous fibroids, Benign endometrial polyps, Uterine septum. Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis. Hemostasis during Surgery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscapic) and open procedures. Neurosurgery: Hemostasis for: Pituitary Tumor; Meningioma; Hemagioblastoma; AVMs; Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma. Oculoplastics: incision, Excision, Vaporization and/or coagulation of tissues in Oculoplastic procedures such as: Operations on the lacrimal system; Operation on the eyelids; Removal of biopsy or orbital tumors; Enucleation on eyeball; Exteneration of orbital contents. Orthopedics: Cutting, ablation, and/or hemostasis of intra-adicular tissue in Orthopedic surgical and arthroscopic applications. Plastic Surgery: Cutting (incision/excision), coagulating, and vaporizing of soft tissue. Pulmonary Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions, including: Squamous Cell Carcinoma; Adenocarcinoma; Carcinoid; Benign Tumors; Granuiomas; Benign Strictures. Thoracic Surgery: Cutting (incision/excision), coagulating, and vaporizing of soft tissue. Thoracic applications including, but not limited to: Isolation of vessels for endarterectomy and/or by-pass grafts; Wedge Resections ; Thoractomy; Formation of Pacemaker pockets. Vaporization, coagulation, incision/excision, debulking, and ablation of fung tissue (Thoracoscopy). Urology: All applications including: Superficial urinary bladder tumors; Invasive bladder carcinoma; Urethral Strictures; Lesions of the extemnal genitalia (including condyloma acuminata).

Source page: https://510kreport.com/device/K990903
Methodology: https://510kreport.com/methodology