LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
Device Facts
| Record ID | K990903 |
|---|---|
| Device Name | LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) |
| Applicant | Laserscope |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Aug 27, 1999 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
The Lyra Surgical Laser System is a semi-portable laser device designed for office and outpatient surgery. It utilizes a Krypton Arc lamp to generate pulsed laser energy at 532 nm (KTP) and 1064 nm (Nd:YAG) wavelengths. The device delivers energy via fiber optic cables to target soft tissue for incision, excision, vaporization, ablation, and coagulation. It features a user interface, chassis, and bezel similar to the Laserscope Aura system. Operators control the laser output using a footswitch or handswitch, with an integrated 630-680 nm laser diode for aiming. The system is used by physicians in various surgical specialties to treat conditions ranging from cutaneous lesions and GI obstructions to gynecological and neurosurgical tumors. By adjusting wavelength and fluence, the device allows for precise tissue interaction—shorter wavelengths (532 nm) for superficial cutting/coagulation and longer wavelengths (1064 nm) for deeper tissue penetration and hemostasis. This provides a versatile tool for surgeons to manage bleeding and remove tissue with minimal invasiveness.
Clinical Evidence
Bench testing only. The device relies on the established safety and efficacy of the predicate Orion laser system, which has prior 510(k) clearance for the same soft tissue applications and laser wavelengths.
Technological Characteristics
Krypton Arc lamp-pumped laser; 532 nm and 1064 nm wavelengths; Multi-mode TEM; 50 Joules max energy; 100 Hz max repetition rate; 1-100 ms pulse width; 0.22 NA coupling; 1-10 mm spot size; coolant-to-air heat exchanger; LCD display; footswitch/handswitch control; 630-680 nm aiming beam. Conforms to 21 CFR 1040.10 and 1040.11.
Indications for Use
Indicated for surgical incision, excision, vaporization, ablation, and coagulation of soft tissue across multiple specialties including dermatology, general surgery, gastroenterology, gynecology, ENT, neurosurgery, ophthalmology, plastic surgery, spinal surgery, thoracic surgery, urology, orthopedics, and pulmonary surgery. Specific patient populations include those with vascular/pigmented lesions, GI obstructions, gynecological conditions (e.g., endometriosis, fibroids), and various tumors. Contraindications include patients not suitable for aggressive laser treatment or those who have not responded to prior laser therapies.
Regulatory Classification
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
Predicate Devices
- Laserscope ORION Surgical Laser System
Submission Summary (Full Text)
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AUG 27 1999
# K 990903
# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS LASERSCOPE Lyra SURGICAL LASER SYSTEM
# REGULATORY AUTHORITY
Safe Medical Device Act of 1990, 21 CFR 807.92
# COMPANY NAME/CONTACT:
Paul Hardiman Laserscope 3052 Orchard Drive San Jose, CA 95134 Phone: 408-943-0636 FAX: 408-934-1454
# DEVICE TRADE NAME
Lyra Surgical Laser System & Accessories
# DEVICE COMMON NAME
Laser Instrument, Surgical, Powered
# DEVICE DESCRIPTION:
The LYRA Laser systems are intended to be semi-portable systems which target the office and small out-patient surgery markets. The laser output characteristics and fiber optical beam delivery method of these LYRA systems are very similar to the Laserscope "Orion" though physically they are much more similar to the Laserscope "Aura" systems. The LYRA systems are based on the same chassis, bezel and user interface as the "Aura" laser systems.
The LYRA Systems described herein are capable of delivering laser energy equivalent to the systems Laserscope currently has in commercial distribution and will operate in the following modes:
·1 to 50 Joule StarPulsed and StarPulsedQ 1.064 micron wavelength laser output at frequencies from single shot to 100 HZ.
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Summary of Safety and Effectiveness, Page 2
DEVICE CLASSIFICATION:
The Lyra Series Surgical Laser System has been classified as a Class II medical device by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels.
### PERFORMANCE STANDARDS
The Lyra Series Surgical Laser System conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.
#### INDICATIONS FOR USE STATEMENT
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, Hemanqiomas, 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).
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# Summary of Safety and Effectiveness, Page 3
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-vitrectory endophotocoagulation of the retina.
Plastic Surgery: Vaporizing, Coagulating, Incising, Excising, debulking, and ablating of soft tissue in endoscopic 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.
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Summary of Safety and Effectiveness, Page 4
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 including: Benign and malignant neoplasm; Angiodysplasia: Polyps: Ulcer; Colitis; Hemorrhoids.
General Surgery: Soft tissue general surgery applications: Skin incision; Tissue dissection; Excision of external tumors and lesions; complete 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. laparoscopic) 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-articular tissue in Orthopedic surgical and arthroscopic applications.
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Summary of Safety and Effectiveness, Page 5
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; Granulomas; 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 ; Thoractorny: Formation of Pacemaker pockets. Vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (Thoracoscopy).
Urology: All applications including: Superficial urinary bladder tumors; Invasive bladder carcinoma; Urethral Strictures; Lesions of the external genitalia (including condyloma acuminata).
TECHNOLOGICAL CHARACTERISTICS
The Lyra is substantially equivalent to Laserscope's Orion lasers which have 510(K) clearance for use on soft tissues
The Orion lasers manufactured by Laserscope have demonstrated the safety and efficacy of using pulsed 532 and 1064 nm light for cutting and coagulating soft tissue. These lasers emit pulsed light with the similar temporal characteristics (pulse durations and PPS), use the same delivery systems, and use similar power densities for treating soft tissue. As the wavelength of light is increased from 532 to 1064 nm the scattering and absorption coefficients of tissue decrease allowing the light to penetrate further into tissue. The limited penetration depth of 532 nm light in tissue makes it useful for cutting soft tissue and at lower fluences coagulating superficial blood vessels. The greater penetration depth of 1064 nm light on the other hand makes it more useful for coagulating soft tissue and large blood vessels.
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# Summary of Safety and Effectiveness, Page 6
# SUBSTANTIAL EQUIVALENCE DETERMINATION:
Since the Lyra Series Surgical Laser System is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device (Laserscope's ORION Surgical Laser System), we believe they clearly meet the requirements for substantial equivalence according to 510(k) guidelines. Safety and effectiveness are reasonable assured, therefore justifying 510(k) clearance.
| Laser type | ND:Yag |
|--------------------------|-------------------------------|
| Laser Pump Source | Krypton Arc lamp |
| Wavelength | 532nm/1064nm |
| TEM Mode | Multi-Mode |
| Maximum Energy per Pulse | 50 Joules |
| Maximum Repetition rate | 100 HZ |
| Pulse width | 1-100 ms |
| Maximum Coupling NA | .22 |
| Treatment Spot sizes | 1-10 mm |
| Cooling System | Coolant to air heat exchanger |
| Display | LCD, Indicator lights |
| Operator Beam Control | Footswitch or Handswitch |
| Aim Beam | 630-680 nm Laser Diode |
### Lyra SPECIFICATIONS
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with flowing lines connecting them. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1999
Mr. Paul H. Hardiman Manager, Regulatory Affairs/Clinical Affairs Laserscope 3052 Orchard Drive San Jose, California 95134
Re: K990903
> Trade Name: Lyra Surgical Laser System and Accessories Regulatory Class: II Product Code: GEX Dated: June 20, 1999 Received: June 22, 1999
Dear Mr. Hardiman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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# Page 2 – Mr. Paul H. Hardiman
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark N Melburn
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Mark N. Melburn
for
ion of General Restorative Devices
### INDICATIONS FOR USE STATEMENT Page 1 of 3
510(k) Number. K 990903
LYRA SERIES SURGICAL LASER SYSTEM & Accessories Device Name:
### 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, Flattening, Flattening, Reduction of lesion size).
General Surgery: Vaporizing, Coagulating, Incising, 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 Vartces, Espohageal 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, ablation, and vessel hemostasis.
Neurosurgery: Incising, excising, coagulating, and vaporizing neurological turnors of the firm textured type.
Opthamology: Post-vitrectomy endophotocoagulation of the retina.
Plastic Surgery: Vaporizing, Coagulating, Incising, Excising, debulking, and ablating of soft tissue in endoscopic and open procedures.
Prescription Use
(Per 21 CFR 801.109)
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ho (D
- on of General Restorative Devices
2 OF 3
### INDICATIONS FOR USE STATEMENT Page 2 of 3
510(k) Number.
K990903
LYRA SERIES SURGICAL LASER SYSTEM & Accessories Device Name:
Spinal Surgery: Percutaneous lumbar diskectomy.
Thoracic Surgery: Vaporizing, Coagulating, Incising, Debulking, and ablating of soft tissue. includina 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: Cholecystectorny, Appendectorny, Vagotomy, Pyloromyotomy.
Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions including Squamous cell carcinoma and Adenocarcinoma; Gastrointestinal hemostasis including: Varices. Espohageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal ulcers, non-bleeding ulcers, Gastric erosions; Gastrointestinal tissue ablation including: Benign and malignant neoplasm; Angiodysplasia; Polyps; Ulcer; Colitis; Hemorrhoids.
General Surgery: Soft tissue general surgery applications: Skin incision; Tissue dissection; Excision of external fumors and lesions; complete or partial resection of internal organs, tumors, lesions; Tissue ablation; Vessel Coagulation.
Gynecology: Treatment of menormagia by photocoagulation of the endometrial lining of the uterus; Ablation of endometrial implants and/or periloneal 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, ablation, and vessel hemostasis.
Prescription Use
(Per 21 CFR 801.109)
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Mark N Millhuser
(Division Sign-Off) vision of General Restorative Devices K 90090 3
3 of 3
### INDICATIONS FOR USE STATEMENT Page 3 of 3
510(k) Number.
K99 0903
LYRA SERIES SURGICAL LASER SYSTEM & Accessories Device Name:
Hemostasis during Surgery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures.
Neurosurgery: Hemostasis for: Pituitary Tumor, Meningioma; Hemagioblastoma; AVMs; Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma.
Oculoplastics: Incision, Excision, Vaponzation 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-anicular tissue in Orthopedic surgical and arthroscopic applications.
Plastic Surgery: Cutting (incision), 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; Granulomas; Benign Strictures.
Thoracic Surgery: Cutting (incision/excision), coaqulating, and vaponizing of soft tissue, Thoracic applications including, but not limited to: Isolation of vessels for endarterectorny and/or by-pass grafts: Wedge Resections : Thoractorny; Formation of Pacemaker pockets. Vaporization, coaqulation, incision/excision, debulking, and ablation of lung tissue (Thoracoscopy).
Urology: All applications including: Superficial urinary bladder tumors: Invasive bladder carcinoma: Urethral Strictures: Lesions of the external genitalia (including condyloma acuminata).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X
or
Over --The-Counter-Use
(per 21 CFR 801.109)
