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K Number
K011703
Device Name
LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES
Manufacturer
LUMENIS
Date Cleared
2001-08-29

(89 days)

Product Code
GEX
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The modified and the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: - urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery. - urology; general surgery; gastroenterology; thoracic & pulmonary surgery; E.N.T. surgery; podiatry; orthopaedics; dermatology and plastic surgery and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy. The modified and the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with accessories are indicated for use in the performance of specific surgical applications in urology, urinary lithotripsy, arthroscopy/orthopaedics, discectomy, E.N.T. surgery, gynecological surgery/gynecology, general surgery, gastroenterology, thoracic and pulmonary surgery, dermatology and plastic surgery, podiatry, and limited indications in neurosurgery and ophthalmology as follows: [Specific indications for each medical specialty and laser type are listed in detail in the document].
Device Description
The Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers that are the subject of this Premarket Notification 510(k) submission are comprised of the following functional components: - a laser console; - control and display panel; - a fiber port for delivery systems; - system microprocessor control electronics; - a covered footswitch or handswitch; - operating software; - an optional remote control unit; - a variety of fiber optic delivery devices with accessories. The Lumenis delivery devices that are the subject of this Premarket Notification 510(k) submission are comprised of all or some (depending on the product configuration) of the following functional components: - laser connector; - handpiece; - probe tube; - probe tip; - fiber optic cable.
More Information

K990947, K002308, K984591, K951910

Not Found

No
The document describes a surgical laser system with standard components like a laser console, control panel, microprocessor, and delivery devices. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of AI/ML. The performance studies focus on safety and effectiveness for surgical applications, not on the performance of an AI/ML algorithm.

Yes.
The device is a surgical laser system intended for use in various surgical procedures, including ablation, vaporization, excision, incision, and coagulation of soft tissue. These are therapeutic interventions designed to treat medical conditions.

No

The device is described as a surgical laser intended for ablation, vaporization, excision, incision, and coagulation of soft tissue. These are therapeutic procedures, not diagnostic ones.

No

The device description explicitly lists multiple hardware components including a laser console, control and display panel, fiber port, system microprocessor control electronics, footswitch/handswitch, optional remote control unit, and various fiber optic delivery devices with accessories. While it mentions "operating software," it is clearly part of a larger hardware system.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes the device as a surgical laser system used for direct surgical procedures on patients (ablation, vaporization, excision, incision, and coagulation of soft tissue). This is an in vivo application, meaning it's used within a living organism.
  • Device Description: The device components (laser console, fiber optic delivery devices, etc.) are consistent with a surgical laser system, not a device designed to analyze samples in vitro (outside the body).
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.

IVD devices are specifically designed to perform tests on samples taken from the body. This device is designed to directly interact with and modify tissue within the body during surgery.

N/A

Intended Use / Indications for Use

The modified and the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with accessories are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including:

  • Ho:YAG: urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery.
  • Nd:YAG: urology; general surgery; gastroenterology; thoracic & pulmonary surgery; E.N.T. surgery; podiatry; orthopaedics; dermatology and plastic surgery; with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy.

The modified and the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with accessories are indicated for use in the performance of specific surgical applications in urology, urinary lithotripsy, arthroscopy/orthopaedics, discectomy, E.N.T. surgery, gynecological surgery/gynecology, general surgery, gastroenterology, thoracic and pulmonary surgery, dermatology and plastic surgery, podiatry, and limited indications in neurosurgery and ophthalmology as follows:

Ho:YAG - Urology

  • Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser enucleation of the prostate (HoLEP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH);
  • Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of:
    • bladder;
    • superficial and invasive bladder, urethral and ureteral tumors;
    • condylomas;
    • lesions of external genitalia;
    • ureteral and penile hemangioma;
    • ureteral strictures;
    • bladder neck obstructions.
  • Urinary Lithotripsy including:
    • endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones;
    • treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed.

Nd:YAG - Urology

  • Urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including:
    • removal of superficial bladder tumors;
    • removal of invasive bladder carcinoma;
    • removal of invasive malignant lesions of the external genitalia, including condylomas;
    • treatment of urethral strictures;
    • treatment of vascularities of the bladder wall;
    • prostatectomy.

Ho:YAG - Arthroscopy

  • Arthroscopy/orthopaedic surgery (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including:
    • meniscectomy;
    • plica removal;
    • ligament and tendon release;
    • contouring and sculpting of articular surfaces;
    • debridement of inflamed synovial tissue (synovectomy);
    • loose body debridement;
    • chondromalacia and tears;
    • lateral retinecular release;
    • capsulectomy in the knee
    • chondroplasty in the knee;
    • chondromalacia ablation.
  • Discectomy including:
    • percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine; open and arthroscopic spine procedures; foraminotomy.

Nd:YAG - Orthopaedic Surgery

  • Arthroscopy (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
    Knee
  • capsulectomy in the knee;
  • chondroplasty in the knee;
  • plica removal in the knee;
  • lateral ligament release in the knee;
  • meniscectomy in the knee;
  • synovectomy in the knee;
  • osteoarthritic lesion removal in the knee.
    Shoulder
  • coracoacromial release in the shoulder;
  • debridement of scar tissue in the shoulder;
  • adhesive capsule release in the shoulder;
  • labral tear repair in the shoulder;
  • synovectomy in the shoulder.
  • Discectomy:
    limited to open, percutaneous and arthroscopic vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine in patients with:
  • unilateral leg pain greater than back pain;
  • paresthetic discomfort in a specific dermatomal distribution;
  • positive straight leg raising test and/or positive bowstring sign;
  • possible neurologic finding including wasting, weakness, sensory alteration and reflex alteration;
  • no improvement after at least 6 weeks of conservative therapy;
  • positive CT or MRI showing a subligamentous herniation at the location consistent with clinical findings.

Ho:YAG - General Surgery

  • Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including:
    • cholecystectomy;
    • lysis of adhesions;
    • appendectomy;
    • appendectomy, biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon;
    • skin incision;
    • tissue dissection;
    • excision of external tumors and lesions;
    • complete or partial resection of internal organs, tumors and lesions;
    • mastectomy;
    • hepatectomy;
    • pancreatectomy;
    • splenectomy;
    • thyroidectomy;
    • parathyroidectomy;
    • herniorrhaphy;
    • tonsillectomy;
    • lymphadenectomy;
    • partial nephrectomy;
    • pilonidal cystectomy;
    • resection of lipoma;
    • debridement of decubitus ulcer;
    • hemorrhoids;
    • debridement of statis ulcer;
    • biopsy.

Nd:YAG - General Surgery

  • Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
    • cholecystectomy;
    • mastectomy;
    • hepatectomy;
    • pancreatectomy;
    • splenectomy;
    • hemorrhoidectomy;
    • thyroidectomy;
    • parathyroidectomy;
    • herniorrhaphy;
    • tonsillectomy;
    • appendectomy;
    • lymphadenectomy;
    • partial nephrectomy;
    • pilonidal cystectomy;
    • resection of lipoma;
    • pelvic adhesiolysis;
    • removal of lesions;
    • removal of polyps;
    • removal of tumors;
    • tumor biopsy;
    • debridement of decubitus ulcers.

Ho:YAG - E.N.T. Surgery

  • Endoscopic endonasal/sinus surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including:
    • partial turbinectomy;
    • ethmoidectomy;
    • polypectomy;
    • maxillary antrostomy;
    • frontal sinusotomy;
    • sphenoidotomy;
    • dacryocystorhinostomy (DCR);
    • functional endoscopic sinus surgery (FESS).

Nd:YAG-E.N.T. Surgery

  • Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
    • lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues;
    • tonsillectomy;
    • adenoidectomy.

Ho:YAG - Gynecological Surgery

  • Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue).

Nd:YAG - Gynecological Surgery

  • Gynecological surgery limited to:
    • treatment of menorrhagia by the photocoagulation, vaporization, or ablation, of the endometrial lining of the uterus under direct hysteroscopic visualization;
    • intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation, and/or vessel coagulation;
    • intra-abdominal treatment of endometriosis and/or peritoneal adhesions with laser contact tips;
    • soft tissue excisional procedures such as excisional conization of the cervix.

Ho:YAG - Gasteroenterology Surgery

  • Open and endoscopic gastroenterology surgery (ablation, vaporization, incision, excision, resection, coagulation and hemostasis, including:
    • gall bladder calculi;
    • biliary / bile duct calculi;
    • benign and malignant neoplasm;
    • polyps;
    • colitis;
    • ulcers;
    • angiodysplasia;
    • hemorrhoids;
    • varices;
    • esophagitis;
    • esophageal ulcer;
    • Mallory-Weiss tear;
    • gastric ulcer;
    • duodenal ulcer;
    • non-bleeding ulcer;
    • gastric erosions;
    • colorectal cancer;
    • gastritis;
    • bleeding tumors;
    • pancreatitis;
    • vascular malformations;
    • telangiectasias;
    • telangiectasias of the Osler-Weber-Renu disease.

Nd:YAG - Gastroenterology Surgery

  • Gastroenterology surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
    • partial removal of neoplastic tissue in the management of esophageal obstruction for symptomatic relief of dysphagia;
    • gastrointestinal hemostasis including, varices, esophagitis, esophageal ulcer, Mallory-Wiess tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, and gastric erosions;
    • gastrointestinal tissue ablation of benign and malignant neoplasm, hemorrhoids and polyps.

Ho:YAG - Pulmonary Surgery

  • Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and coagulation of soft tissue).

Nd:YAG - Thoracic and Pulmonary Surgery

  • Thoracic and pulmonary surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including treatment of:
    • laryngeal lesions;
    • airway obstructions including carcinoma;
    • polyps and granulomas;
    • palliation of obstructing carcinomas of the tracheobronchial tree.

Ho:YAG - Dermatology and Plastic Surgery

  • Incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft, mucosal, fatty and cartilaginous tissues, in therapeutic plastic, dermatologic and aesthetic surgical procedures, including:
    • scars;
    • tattoo removal;
    • vascular lesions;
    • port wine stains;
    • hemangioma;
    • telangiectasia of the face and leg;
    • rosacea;
    • corns;
    • papillomas;
    • basal cell carcinomas;
    • lesions of skin and subcutaneous tissue;
    • plantar warts;
    • periungual and subungual warts;
    • debridement of decubitus ulcer;
    • skin tag vaporization.

Nd:YAG - Dermatology and Plastic Surgery

  • Dermatology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
    • lesions of skin and subcutaneous tissue;
    • telangiectasia;
    • port wine lesions;
    • spider veins;
    • hemangiomas;
    • plantar warts;
    • periungual and subungual warts;
    • removal of tattoos;
    • debridement of decubitus ulcer;
    • treatment of keloids.

Nd:YAG - Podiatry

  • Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
    • matrixectomy;
    • plantar warts;
    • neuromas;
    • periungual and subungual warts;
    • radical nail excision.

Nd:YAG - Neurosurgery

  • Neurosurgery limited to:
    • hemostasis in neurosurgery procedures such as excision of brain lesions, spinal cord lesions, cranial nerves, peripheral nerves, and pituitary glands.

Nd:YAG - Ophthalmology

  • Ophthalmology limited to:
    • post-vitrectomy photocoagulation.

Product codes (comma separated list FDA assigned to the subject device)

GEX

Device Description

The Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers that are the subject of this Premarket Notification 510(k) submission are comprised of the following functional components:

  • a laser console;
  • control and display panel;
  • a fiber port for delivery systems;
  • system microprocessor control electronics;
  • a covered footswitch or handswitch;
  • operating software;
  • an optional remote control unit;
  • a variety of fiber optic delivery devices with accessories.

The Lumenis delivery devices that are the subject of this Premarket Notification 510(k) submission are comprised of all or some (depending on the product configuration) of the following functional components:

  • laser connector;
  • handpiece;
  • probe tube;
  • probe tip;
  • fiber optic cable.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Soft tissue, cartilaginous tissue, bone, various small and large joints (excluding the spine), L4-5 and L5-S1 lumbar discs of the vertebral spine, prostate, bladder, urethra, ureter, external genitalia, bladder neck, kidney, sigmoid colon, skin, internal organs, external tumors, lesions, breast, liver, pancreas, spleen, thyroid, parathyroid, lymph nodes, pilonidal cyst, lipoma, decubitus ulcer, hemorrhoids, nasal passage, sinuses, ethmoid, polyps, maxillary sinus, frontal sinus, sphenoid, lacrimal sac, dacryocyst, oral cavity, pharynx, larynx, tonsils, adenoids, uterus, endometrium, fibroids, endometrial polyps, uterine septum, fallopian tubes, ovaries, peritoneum, cervix, gall bladder, biliary/bile duct, GI tract (esophagus, stomach, duodenum, colon), vascular structures, tracheobronchial tree, scars, tattoos.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K990947, K002308, K984591, K951910

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

0

AUG 2 9 2001

Attachment 11

K 011703

510(k) Summary Statement for the Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories

I. General Information

| Submitter: | Lumenis
2400 Condensa Street
Santa Clara, California, U. S. A.
95051-0901 |
|---------------------------|------------------------------------------------------------------------------------|
| Contact Person: | Lisa G. McGrath |
| Summary Preparation Date: | May 30, 2001 |

  • II. Names
    PowerSuite VersaPulse Device Names: Modified Lumenis Dual Wavelength (Ho:YAG) and Holmium (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories Surgical Instrument (and Powered Primary Classification Name: Laser Accessories)

III. Predicate Devices

  • and VersaPulse PowerSuite Holmium (Ho:YAG) Dual Wavelength . (Ho:YAG/Nd:YAG) Surgical Lasers (K990947);
  • Trimedyne Holmium Laser Systems (model 1210, model 1010-VHP, and model . 1500-A) (K002308)
  • Dornier Medilas H/2 Laser System (K984591) .
  • Convergent Odyssey 30 Laser System (K951910). .

IV. Product Description

The Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers that are the subject of this Premarket Notification 510(k) submission are comprised of the following functional components:

  • a laser console;
  • control and display panel;

1

  • a fiber port for delivery systems; .
  • system microprocessor control electronics; •
  • a covered footswitch or handswitch; .
  • . operating software;
  • an optional remote control unit; .
  • a variety of fiber optic delivery devices with accessories. .

The Lumenis delivery devices that are the subject of this Premarket Notification 510(k) submission are comprised of all or some (depending on the product configuration) of the following functional components:

  • laser connector;
  • handpiece;
  • probe tube;
  • probe tip;
  • fiber optic cable.

V. Indications for Use

The modified and the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including:

  • urology; urinary lithotripsy; arthroscopy; discectomy; Ho:YAG o E.N.T. surgery; gynecological surgery; ppulmonary surgery : gastroenterology surgery; dermatology and plastic surgery and general surgery.
  • urology; general surgery; gastroenterology; thoracic & Nd:YAG o pulmonary surgery; E.N.T. surgery; podiatry; orthopaedics; dermatology and plastic surgery and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy.

The modified and the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are indicated for use in the performance of specific surgical applications in urology, urinary lithotripsy, arthroscopy/orthopaedics, discectomy, E.N.T. surgery, gynecological surgery/gynecology, general surgery, gastroenterology, thoracic and pulmonary surgery, dermatology and plastic surgery, podiatry, and limited indications in neurosurgery, ophthalmology, and lumbar discectomy as follows:

2

Page 3

Ho:YAG - Urology

  • endoscopic transurethral incision of the prostate (TUIP), bladder neck ● incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser enucleation of the prostate (HoLEP),holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH);
  • open and endoscopic urological surgery (ablation, vaporization, incision, . excision and coagulation of soft tissue) including treatment of:
    • bladder; O
    • superficial and invasive bladder, urethral and ureteral tumors; O
    • condylomas; O
    • lesions of external genitalia; o
    • ureteral and penile hemangioma; O
    • 0 ureteral strictures;
    • bladder neck obstructions. o
  • Urinary Lithotripsy including: .
    • endoscopic fragmentation of urinary (urethral, ureteral, bladder and o renal) calculi, including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones;
    • treatment of distal impacted fragments of steinstrasse when guide wires o cannot be passed.

Nd:YAG - Urology

  • Urological surgery (ablation, vaporization, incision, excision and coagulation ● of soft tissue) including:
    • removal of superficial bladder tumors; O
    • removal of invasive bladder carcinoma; 0
    • removal of benign or malignant lesions of the external genitalia, including 0 condylomas;
    • treatment of urethral strictures; O
    • treatment of vascularities of the bladder wall; O
    • prostatectomy. 0

Ho:YAG - Arthroscopy

  • Arthroscopy/orthopaedic surgery (ablation, excision and coagulation of soft ● and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including:
    • meniscectomy; o
    • o plica removal;

3

  • ligament and tendon release; 0
  • contouring and sculpting of articular surfaces; 0
  • debridement of inflamed synovial tissue (synovectomy); o
  • loose body debridement; O
  • chondromalacia and tears; O
  • lateral retinecular release; O
  • capsulectomy in the knee 0
  • chondroplasty in the knee; O
  • chondromalacia ablation. O
  • . Discectomy including:
    • percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the o vertebral spine; open and arthroscopic spine procedures; foraminotomy.

Nd:YAG - Orthopaedic Surgery

  • Arthroscopy (ablation, vaporization, incision, excision, and coagulation of . soft tissue) including:
    Knee

  • capsulectomy in the knee; O

  • chondroplasty in the knee; O

  • plica removal in the knee; 0

  • lateral ligament release in the knee; 0

  • meniscectomy in the knee; ಂ

  • synovectomy in the knee; O

  • osteoarthritic lesion removal in the knee; 0

Shoulder

  • coracoacromial release in the shoulder; 0
  • debridement of scar tissue in the shoulder; 0
  • adhesive capsule release in the shoulder; 0
  • labral tear repair in the shoulder; 0
  • synovectomy in the shoulder. O
  • . Discectomy:

limited to open, percutaneous and arthroscopic vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine in patients with:

  • unilateral leg pain greater than back pain; O
  • paresthetic discomfort in a specific dermatomal distribution; O
  • O positive straight leg raising test and/or positive bowstring sign;
  • possible neurologic finding including wasting, weakness, sensory 0 alteration and reflex alteration;
  • no improvement after at least 6 weeks of conservative therapy; O

4

Page 5

  • positive CT or MRI showing a subligamentous herniation at the location O consistent with clinical findings.

Ho:YAG - General Surgery

  • Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, . incision, and coagulation of soft tissue) including:
    • cholecystectomy; ಂ
    • lysis of adhesions; O
    • appendectomy; o
    • appendectorny, and removal of polyps of the sigmoid colon; o
    • skin incision; 0
    • tissue dissection; o
    • excision of external tumors and lesions; 0
    • complete or partial resection of internal organs, tumors and lesions; 0
    • mastectomy; 0
    • hepatectomy; 0
    • pancreatectomy; 0
    • splenectomy; o
    • thyroidectomy; 0
    • parathyroidectomy; o
    • herniorrhaphy; O
    • tonsillectomy; O
    • lymphadenectomy; 0
    • partial nephrectomy; 0
    • pilonidal cystectomy; O
    • resection of lipoma; 0
    • debridement of decubitus ulcer; O
    • hemorrhoids; O
    • debridement of statis ulcer; 0
    • biopsy. O

Nd:YAG - General Surgery

  • Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, . incision, excision, and coagulation of soft tissue) including:
    • cholecystectomy; o
    • mastectomy; 0
    • hepatectomy; O
    • pancreatectomy; ಂ
    • o splenectomy;
    • hemorrhoidectomy; o

5

  • thyroidectomy; ಂ
  • parathyroidectomy; ಂ
  • herniorrhaphy; ಂ
  • tonsillectomy; O
  • appendectomy; 0
  • lymphadenectomy; O
  • partial nephrectomy; 0
  • pilonidal cystectomy; O
  • resection of lipoma; 0
  • O pelvic adhesiolysis;
  • removal of lesions; O
  • removal of polyps; O
  • removal of tumors; 0
  • tumor biopsy; O
  • debridement of decubitus ulcers. O

Ho:YAG - E.N.T. Surgery

  • . Endoscopic endonasal/sinus surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including:
    • partial turbinectomy; 0
    • ethmoidectomy; 0
    • polypectomy; o
    • maxillary antrostomy; 0
    • frontal sinusotomy; o
    • sphenoidotomy; o
    • dacryocystorhinostomy (DCR); O
    • O functional endoscopic sinus surgery (FESS).

Nd:YAG-E.N.T. Surgery

  • Endonasal surgery (ablation, vaporization, incision, excision, and coagulation . of soft tissue) including:
    • o lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues;
    • tonsillectomy; O
    • adenoidectomy. O

Ho:YAG - Gynecological Surgery

  • Open and laparoscopic gynecological surgery (ablation, vaporization, . incision, excision, and coagulation of soft tissue).

Nd:YAG - Gynecological Surgery

  • . Gynecological surgery limited to:

6

Page 7

  • treatment of menorrhagia by the photocoagulation, vaporization, or o the endometrial lining of the uterus under direct ablation, of hysteroscopic visualization;
  • intra-uterine treatment of submucous fibroids, benign endometrial o polyps, and uterine septum by incision, excision, ablation, and/or vessel coagulation;
  • intra-abdominal treatment of endometriosis and/or peritoneal adhesions O with laser contact tips;
  • soft tissue excisional procedures such as excisional conization of the O cervix.

Ho:YAG - Gasteroenterology Surgery

  • Open and endoscopic gasteroenterology surgery (ablation, vaporization, . incision, excision, resection, coagulation and hemostasis, including:
    • O gall bladder calculi;
    • biliary/bile duct calculi; O
    • benign and malignant neoplasm; 0
    • polyps; 0
    • colitis; O
    • 0 ulcers;
    • angiodysplasia; 0
    • hemorrhoids; 0
    • varices; 0
    • esophagitis; 0
    • esophageal ulcer; O
    • Mallory-Weiss tear; O
    • gastric ulcer; 0
    • O duodenal ulcer;
    • non-bleeding ulcer; O
    • gastric erosions; ಂ
    • colorectal cancer; o
    • gastritis; O
    • bleeding tumors; o
    • pancreatitis; ಂ
    • O vascular malformations;
    • telangiectasias; 0
    • telangiectasias of the Osler-Weber-Renu disease. 0

Nd:YAG - Gastroenterology Surgery

  • . Gastroenterology surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
    • partial removal of neoplastic tissue in the management of esophageal O obstruction for symptomatic relief of dysphagia;

7

Page 8

  • gastrointestinal hemostasis including, varicies, esophagitis, esophageal O ulcer, Mallory-Wiess tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, and gastric erosions;
  • gastrointestinal tissue ablation of benign and malignant neoplasm, 0 hemorrhoids and polyps.

Ho:YAG - Pulmonary Surgery

  • Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, . incision, excision and coagulation of soft tissue).

Nd:YAG - Thoracic and Pulmonary Surgery

  • Thoracic and pulmonary surgery (ablation, vaporization, incision, excision, . and coagulation of soft tissue) including treatment of:
    • laryngeal lesions; ಂ
    • airway obstructions including carcinoma; 0
    • polyps and granulomas; O
    • palliation of obstructing carcinomas of the tracheobronchial tree. 0

Ho:YAG - Dermatology and Plastic Surgery

  • excision, resection, ablation, coagualation, hemostasis and . Incision, vaporization of soft, mucosal, fatty and cartilaginous tissues, in therapeutic plastic, dermatologic and aesthetic surgical procedures, including:
    • scars; o
    • tattoo removal; O
    • vascular lesions; o
    • port wine stains; o
    • ಂ hemangioma;
    • telangiectasia of the face and leg; 0
    • O rosacea;
    • corns; 0
    • papillomas; O
    • basal cell carcinomas; O
    • lesions of skin and subcutaneous tissue; 0
    • plantar warts; o
    • periungual and subungual warts; o
    • debridement of decubitus ulcer; O
    • skin tag vaporization. O

Nd:YAG - Dermatology and Plastic Surgery

  • Dermatology and plastic surgery (ablation, vaporization, incision, excision, . and coagulation of soft tissue) including:
    • lesions of skin and subcutaneous tissue; O
    • telangiectasia; o
    • port wine lesions; O

8

  • spider veins; O
  • hemangiomas; 0
  • 0 plantar warts;
  • periungual and subungual warts; O
  • removal of tattoos; O
  • debridement of decubitus ulcer; 0
  • treatment of keloids. O

Nd:YAG - Podiatry

  • . Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
    • matrixectomy; o
    • plantar warts; 0
    • neuromas; ರ
    • periungual and subungual warts; O
    • radical nail excision. O

Nd:YAG - Neurosurgery

  • Neurosurgery limited to: .
    • hemostasis in neurosurgery procedures such as excision of brain lesions, o spinal cord lesions, cranial nerves, peripheral nerves, and pituitary glands.

Nd:YAG - Ophthalmology

  • Ophthalmology limited to: ●
    • o post-vitrectomy photocoagulation.

V. Rationale for Substantial Equivalence

The Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories share the same intended use, indications for use, similar design features, functional features, and therefore are substantially equivalent to the PowerSuite Holmium (Ho:YAG) and Dual Wavelength VersaPulse (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories.

In addition, the Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are substantially equivalent in terms of indications for use to the Trimedyne Holmium Laser Systems (model 1210, model 1010-VHP, and model 1500-A) (K002308), the Dornier Medilas H/2 Laser System (K984591) and the Convergent Odyssey 30 Laser System (K951910).

9

The Lumenis delivery devices are substantially equivalent to the previously cleared delivery devices in K990947.

VII. Safety and Effectiveness Information

Safety and effectiveness information was provided to demonstrate that the Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories are safe and effective, when indicated for use for general and specific applications in the medical specialties of urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery, gastroenterology surgery, dermatology and plastic surgery and general surgery; for Ho:YAG and urology; general surgery; gastroenterology; thoracic and pulmonary surgery; E.N.T. surgery; podiatry; orthopaedics; and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy for Nd:YAG.

Conclusion VIII.

The Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories were found to be substantially equivalent to similar currently marketed and predicate surgical lasers, delivery devices and accessories.

The Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories share the same intended use, indications for use, similar design features, and similar functional features as the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories. The Modified Lumenis PowerSuite Holmium (Ho:YAG) and Dual Wavelength VersaPulse (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories is also substantially equivalent in terms of indications for use to the Trimedyne Holmium Laser Systems (model 1210, model 1010-VHP, and model 1500-A) (K002308), the Dornier Medilas H/2 Laser System (K984591) and the Convergent Odyssey 30 Laser System (K951910).

10

Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.

AUG 2 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa G. McGrath Senior Regulatory Affairs Associate Lumenis 2400 Condensa Street Santa Clara, California 95051

Re: K011703

Trade/Device Name: Modified Lumenis VersaPulse® PowerSuite®™ Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers & Delivery Devices with Accessories

Devices with Accessories
. 878 4810

Regulation Number: 878.4810 Regulatory Class: II Product Code: GEX Dated: May 30, 2001 Received: June 1, 2001

Dear Ms. McGrath:

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 legally marketed predicate 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 requirements, 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.

11

Page 2 - Ms. Lisa G. McGrath

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 notification. The I Driving of succion 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 II you desire specific advices), your actices), please contact the Office of Compliance at additionally 807.10 for mirrito than its promotion and advertising of your device, (301) 594-4639. Traditionally, appliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibilities and er Assistance at its toll-free number (800) 638-2041 or Manufacturers Internet and Colless "http://www.fda.gov/cdrh/dspa/dsmamain.html".

Sincerely yours,

l Mark n Millkenso

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

12

Attachment 3 Indications For Use Statement

510(k) Number (if Known):KD111703
-------------------------------------

Device Name: Modified Lumenis VersaPulse® PowerSuite™ Holmium (Ho:YAG) and Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers & Delivery Dual Devices with Accessories

Indications For Use:

The modified and the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) The Inounced and the colors (Ho:YAG) Surgical Lasers and Delivery Devices with and Duar Warelengan (sfor use in surgical procedures involving open, laparoscopic and accessories are antention, excision, excision, incision, and coagulation of soft tissue in medical specialties including:

  • urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. . Ho:YAG surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery.
  • urology; general surgery; gastroenterology; thoracic & pulmonary Nd:YAG -. I N.T.T. surgery; podiatry; orthopaedics; dermatology and plastic surgery; surgery El With limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy.

The modified and the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) The Inounced and the PHG/Nd:YAG) Surgical Lasers and Delivery Devices with accessories are indicated for use in the performance of specific surgical applications in uccebooks urinary lithotripsy, arthroscopy/orthopaedics, discectomy, E.N.T. surgery, gynecological surgery/gynecology, general surgery, gastroenterology, thoracic and 57.00000gear enatology and plastic surgery, podiatry, and limited indications in neurosurgery and ophthalmology as follows:

*** Indications For Use Continued on Next Page (9 pages total) ***

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Mark of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number
Prescription Use
(Per 21 CFR 801.109)

K
Or

Over-The-Counter Use (Optional Format 1-2-96)

13

Attachment 3 -- Continued (page 2 of 9) Indications For Use Statement

510(k) Number (if Known):_

Device Name: Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Modified Lumicino Ho:YAGNd:YAG) Surgical Lasers and Delivery Devices with Accessories

Indications For Use:

Ho:YAG - Urology

  • Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of . Endoscopic trailSureunan incision of the prostate (HoLAP), holmium in the prostate (UNI), nominatif itser as the Resertion of the prostate laser enucleation of the prosule (110222)// hours for treatment of benign prostatic hypertrophy (BPH);
  • hypertropliy (DFTI),
    Open and endoscopic urological surgery (ablation, vaporization, incision, Open "and coagulation of soft tissue) including treatment of:
    • bladder; O
    • Diadder,
      superficial and invasive bladder, urethral and ureteral tumors; o
    • condylomas; 0
    • lesions of external genitalia; o
    • ureteral and penile hemangioma; O
    • ureteral strictures; O
    • bladder neck obstructions. o
  • Urinary Lithotripsy including:
    • y Elthouripsy therating.
      endoscopic fragmentation of urinary (urethral, ureteral, bladder and O encobcopic ii againding cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones;
    • calcrail oxalate anympacted fragments of steinstrasse when guide wires 0 cannot be passed.

Nd:YAG - Urology

  • Urological surgery (ablation, vaporization, incision, excision and coagulation of . soft tissue) including:
    • removal of superficial bladder tumors; o
    • removal of invasive bladder carcinoma; 0
    • removal of invasive malignant lesions of the external genitalia, including O condylomas;
    • treatment of urethral strictures; O
    • treatment of vascularities of the bladder wall;
    • prostatectomy.

Mark n millers
Division Sign-Off

Division of General, Restorative

510(k) Number K

14

Attachment 3- Continued (page 3 of 9) Indications For Use Statement

510(k) Number (if Known):_

Device Name: Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories

Indications for Use:

Ho:YAG - Arthroscopy

  • G = Artifioscopy (ablation, excision and coagulation of soft and cartilaginous tissue) � Arthroscopy (ablandit) excluding and coup.
    in various small and large joints of the body, excluding the spine, including:
    • meniscectomy; o
    • plica removal; 0
    • ligament and tendon release; 0
    • contouring and sculpting of articular surfaces; 0
    • contidement of inflamed synovial tissue (synovectomy); 0
    • loose body debridement; 0
    • chondromalacia and tears; 0
    • lateral retinecular release; 0
    • capsulectomy in the knee 0
    • chondroplasty in the knee; o
    • chondromalacia ablation. O
  • Discectomy including: .
    • tomy including.
      percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the o perculaneous vaporization throscopic spine procedures; foraminotomy.

Nd:YAG - Orthopaedic Surgery

  • Arthroscopy (ablation, vaporization, incision, excision, and coagulation of soft ● tissue) including:
    Knee

  • capsulectomy in the knee; O

  • chondroplasty in the knee; O

  • plica removal in the knee; O

  • lateral ligament release in the knee; o

  • meniscectomy in the knee; O

  • synovectomy in the knee; 0

  • osteoarthritic lesion removal in the knee; o

Shoulder

  • coracoacromial release in the shoulder; O
  • debridement of scar tissue in the shoulder;

Mark N. Milbauer

on of General. Restorative

510(k) Number K

15

Attachment 3 - Continued (page 4 of 9) Indications For Use Statement

510(k) Number (if Known):_

Device Name: Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories

Indications For Use:

Nd:YAG - Orthopaedic Surgery - Continued

  • adhesive capsule release in the shoulder; o
  • labral tear repair in the shoulder; o
  • synovectomy in the shoulder. o

Discectomy: .

Discectority.
Imited to open, percutaneous and arthroscopic vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine in patients with:

  • unilateral leg pain greater than back pain; O
    • annateral leg paint ---------------------------------------------------------------------------------------------------------------------------------------------------------o
    • positive straight leg raising test and/or positive bowstring sign; O
  • possible neurologic finding including wasting, weakness, sensory 0 alteration and reflex alteration;
  • no improvement after at least 6 weeks of conservative therapy; O
  • positive CT or MRI showing a subligamentous herniation at the O location consistent with clinical findings.

Ho:YAG - General Surgery

.

  • Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including:
    • cholecystectomy; 0
    • lysis of adhesions; O
    • appendectomy; 0
    • appendectorry/
      biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon; ಂ
    • skin incision; 0
    • tissue dissection; ೦
    • excision of external tumors and lesions; 0
    • complete or partial resection of internal organs, turnors and lesions; O
    • mastectomy; ಂ
    • hepatectomy; O
    • pancreatectomy; O
    • splenectomy; ಂ
    • thyroidectomy; 0
    • parathyroidectomy; 0

Mark N Milken

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

510(k) Number

16

Attachment 3 - Continued (page 5 of 9) Indications For Use Statement

510(k) Number (if Known):_

Device Name: Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories

Indications For Use:

Ho:YAG - General Surgery - Continued

o herniorrhaphy;

o tonsillectomy;

o lymphadenectomy;

o partial nephrectomy;

o pilonidal cystectomy;

o resection of lipoma;

o debridement of decubitus ulcer;

o hemorrhoids;

o debridement of statis ulcer;

o biopsy.

Nd:YAG - General Surgery

  • Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, . incision, excision, and coagulation of soft tissue) including:
    • cholecystectomy; o
    • mastectomy; o
    • hepatectomy; 0
    • pancreatectomy; 0
    • splenectomy; O
    • hemorrhoidectomy; 0
    • thyroidectomy; O

parathyroidectomy; O

  • herniorrhaphy; 0
    tonsillectomy; 0

  • appendectomy; 0

  • lymphadenectomy; 0

partial nephrectomy; O

  • pilonidal cystectomy; O
    resection of lipoma; 0

  • pelvic adhesiolysis; O

  • removal of lesions; O

  • removal of polyps; O

  • removal of tumors; o

tumor biopsy; O

debridement of decubitus ulcers. O

to Mark N Mulbernan

011703

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number

Attachment 3, Page 5

17

Attachment 3 - Continued (page 6 of 9) Indications For Use Statement

510(k) Number (if Known):

Device Name: Modified Lumenis VersaPulse Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories

Indications For Use:

Ho: YAG - E.N.T. Surgery

  • Endoscopic endonasal/sinus surgery (ablation, vaporization, incision, and . coagulation of soft tissue and cartilage) including:
    • partial turbinectomy; o
    • ethmoidectomy; O
    • polypectomy; O
    • maxillary antrostomy; 0
    • frontal sinusotomy; ಂ
    • sphenoidotomy; O
    • dacryocystorhinostomy (DCR); o

eral, Restorative and Neurological Devices

  • dacryocystoriumostomy (DCx), "FESS)10(k) Number -O

Nd:YAG-E.N.T. Surgery

  • Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of . soft tissue) including:
    • lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal o tissues:
    • tonsillectomy; O
    • adenoidectomy. o

Ho:YAG - Gynecological Surgery

.

  • Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue).

Nd:YAG - Gynecological Surgery

  • Gynecological surgery limited to: .
    • treatment of menorrhagia by the photocoagulation, vaporization, or o ablation, of the endometrial lining of the uterus under direct hysteroscopic visualization;
    • intra-uterine treatment of submucous fibroids, benign endometrial O polyps, and uterine septum by incision, excision, ablation, and/or vessel coagulation;
    • intra-abdominal treatment of endometriosis and/or peritoneal adhesions O with laser contact tips;
    • soft tissue excisional procedures such as excisional conization of the O cervix.

18

Attachment 3 - Continued (page 7 of 9) Indications For Use Statement

510(k) Number (if Known):_

Device Name: Modified Lumenis VersaPulse Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories

Indications For Use:

Ho:YAG - Gasteroenterology Surgery

  • Open and endoscopic gasteroenterology surgery (ablation, vaporization, . incision, excision, resection, coagulation and hemostasis, including:
    • gall bladder calculi; o
    • biliary / bile duct calculi; ಂ
    • o benign and malignant neoplasm;
    • polyps; ಂ
    • colitis; o
    • ulcers; 0
    • angiodysplasia; 0
    • hemorrhoids; o
    • varices; O
    • esophagitis; 0
    • esophageal ulcer; 0
    • Mallory-Weiss tear; 0
    • gastric ulcer; O
    • duodenal ulcer; O
    • non-bleeding ulcer; O
    • gastric erosions; 0
    • colorectal cancer; 0
    • gastritis; O
    • bleeding tumors; O
    • pancreatitis; O
    • vascular malformations; O
    • telangiectasias; 0
    • telangiectasias of the Osler-Weber-Renu disease. 0

Nd:YAG - Gastroenterology Surgery

  • Gastroenterology surgery (ablation, vaporization, incision, excision, and � coagulation of soft tissue) including:
    • partial removal of neoplastic tissue in the management of esophageal O obstruction for symptomatic relief of dysphagia;
    • gastrointestinal hemostasis including, varicies, esophagitis, esophageal O ulcer, Mallory-Wiess tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, and gastric erosions;
    • gastrointestinal tissue ablation of benign and malignant neoplasm, 0 hemorrhoids and polyps.

Mark N Milburn

Division Sign-Off Division of General, Restorative and Neurological Devices KO11903

510(k) Number -

19

Attachment 3 - Continued (page 8 of 9) Indications For Use Statement

510(k) Number (if Known):

Device Name: Modified Lumenis VersaPulse Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories

Indications For Use:

Ho:YAG - Pulmonary Surgery

  • . Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and coagulation of soft tissue).

Nd:YAG - Thoracic and Pulmonary Surgery

  • Thoracic and pulmonary surgery (ablation, vaporization, incision, excision, and . coagulation of soft tissue) including treatment of:
    • laryngeal lesions; o
    • airway obstructions including carcinoma; 0
    • polyps and granulomas; 0
    • palliation of obstructing carcinomas of the tracheobronchial tree. 0

Ho:YAG - Dermatology and Plastic Surgery

  • Incision, excision, resection, ablation, coagualation, hemostasis and vaporization . of soft, mucosal, fatty and cartilaginous tissues, in therapeutic plastic, dermatologic and aesthetic surgical procedures, including:
    • scars; O
    • tattoo removal; O
    • vascular lesions; 0
    • O port wine stains;
    • hemangioma; 0
    • telangiectasia of the face and leg; O
    • rosacea; 0
    • corns; 0
    • papillomas; O
    • basal cell carcinomas; 0
    • lesions of skin and subcutaneous tissue; 0
    • plantar warts; ಂ
    • periungual and subungual warts; O
    • debridement of decubitus ulcer; O
    • skin tag vaporization. O

for Mark n Mulkers

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_

Attachment 3, Page 8

20

Attachment 3 - Continued (page 9 of 9) Indications For Use Statement

510(k) Number (if Known):_

Device Name: Modified Lumenis VersaPulse Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories

Indications For Use:

Nd:YAG - Dermatology and Plastic Surgery

  • Dermatology and plastic surgery (ablation, vaporization, incision, excision, and . coagulation of soft tissue) including;
    • lesions of skin and subcutaneous tissue; o
    • telangiectasia; o
    • port wine lesions; 0
    • spider veins; O
    • hemangiomas; 0
    • plantar warts; 0
    • periungual and subungual warts; 0
    • removal of tattoos; O
    • debridement of decubitus ulcer; 0
    • treatment of keloids. O

Nd:YAG - Podiatry

  • Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) . including:
    • matrixectomy; o
    • plantar warts; 0
    • neuromas; 0
    • periungual and subungual warts; 0
    • radical nail excision. ರ

Nd:YAG - Neurosurgery

.

  • Neurosurgery limited to:
    • hemostasis in neurosurgery procedures such as excision of brain lesions, o cranial nerves, peripheral nerves, and pituitary spinal cord lesions, glands.

Nd:YAG - Ophthalmology

  • Ophthalmology limited to: ●
    • post-vitrectomy photocoagulation. ಂ

***(page 9 of 9) ***

Attachment 3, Page 9

Mark n Mullerson
Division Sign-Off

510(k) Number