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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Modified Lumenis VersaPulse PowerSuite Surgical Lasers:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary statement does not include explicit, quantifiable acceptance criteria or performance metrics for the modified device. Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices.

Therefore, the table below will reflect the nature of the information provided, which is a claim of substantial equivalence for intended use, indications for use, design, and functional features.

Acceptance Criterion (Implicit from Substantial Equivalence Claim)	Reported Device Performance
Intended Use: Functionally equivalent to predicate devices.	The Modified Lumenis VersaPulse PowerSuite Surgical Lasers share the same intended use as the currently marketed and predicate surgical lasers.
Indications for Use: Equivalent to predicate devices.	The Modified Lumenis VersaPulse PowerSuite Surgical Lasers share the same indications for use as the currently marketed and predicate surgical lasers.
Design Features: Similar to predicate devices.	The Modified Lumenis VersaPulse PowerSuite Surgical Lasers have similar design features as the currently marketed and predicate surgical lasers.
Functional Features: Similar to predicate devices.	The Modified Lumenis VersaPulse PowerSuite Surgical Lasers have similar functional features as the currently marketed and predicate surgical lasers.
Safety and Effectiveness: Equivalent to predicate devices.	Safety and effectiveness information was provided to demonstrate that the modified devices are safe and effective when used as indicated, implicitly equivalent to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on the concept of substantial equivalence, meaning that new clinical studies with test sets are generally not required if the device is sufficiently similar to legally marketed predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document does not describe a clinical study with a test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable as the document does not describe a clinical study with a test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this document. The submission is for a surgical laser system, which is a physical medical device, not an AI or imaging diagnostic tool that would typically undergo MRMC studies. The concept of "human readers improving with AI vs. without AI assistance" does not apply to this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm-only performance study was not done. This device is a laser surgical system, which inherently requires human-in-the-loop operation by a trained medical professional.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically understood in studies validating diagnostic or AI devices (e.g., pathology, outcomes data) is not directly applicable here. For this 510(k) submission, the "ground truth" for demonstrating safety and effectiveness implicitly relies on:

Established safety and efficacy of the predicate devices: The primary argument is that because the modified device is substantially equivalent to predicate devices that have already been deemed safe and effective, the modified device also meets these criteria.
Engineering and performance testing: While not detailed in this summary, the submission would have included technical performance data demonstrating that the laser meets its specifications and operates safely within expected parameters (e.g., power output, wavelength, pulse duration). This testing serves as the "ground truth" for the device's physical performance, but not in the clinical diagnostic sense.

8. The Sample Size for the Training Set

This information is not applicable. This document describes a surgical laser device, not an AI or machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this type of device.

Summary

{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:	Lumenis2400 Condensa StreetSanta 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

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. .

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

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

Regulation Number and Section

§ 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.

AUG 2 9 2001

I. General Information

III. Predicate Devices

IV. Product Description

V. Indications for Use

Page 3

Ho:YAG - Urology

Nd:YAG - Urology

Ho:YAG - Arthroscopy

Nd:YAG - Orthopaedic Surgery

Shoulder

Page 5

Ho:YAG - General Surgery

Nd:YAG - General Surgery

Ho:YAG - E.N.T. Surgery

Nd:YAG-E.N.T. Surgery

Ho:YAG - Gynecological Surgery

Nd:YAG - Gynecological Surgery

Ho:YAG - Gasteroenterology Surgery

Nd:YAG - Gastroenterology Surgery

Ho:YAG - Pulmonary Surgery

Nd:YAG - Thoracic and Pulmonary Surgery

Ho:YAG - Dermatology and Plastic Surgery

Nd:YAG - Dermatology and Plastic Surgery

Nd:YAG - Podiatry

Nd:YAG - Neurosurgery

V. Rationale for Substantial Equivalence

VII. Safety and Effectiveness Information

Conclusion VIII.

Attachment 3 Indications For Use Statement

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:

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

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

Nd:YAG - Urology

Indications for Use:

Ho:YAG - Arthroscopy

Nd:YAG - Orthopaedic Surgery

Shoulder

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

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:

Discectomy: .

Ho:YAG - General Surgery

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

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 - General Surgery

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

Nd:YAG-E.N.T. Surgery

Ho:YAG - Gynecological Surgery

Nd:YAG - Gynecological Surgery

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

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 - Gastroenterology Surgery

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

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

Ho:YAG - Pulmonary Surgery

Nd:YAG - Thoracic and Pulmonary Surgery

Ho:YAG - Dermatology and Plastic Surgery

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

Indications For Use:

Nd:YAG - Neurosurgery

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

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