PROFILE 2000/3000 LASER SYSTEM

K040005 · Sciton, Inc · GEX · Mar 29, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040005
• Device Name: PROFILE 2000/3000 LASER SYSTEM
• Applicant: Sciton, Inc
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Profile 2000 Laser System, and Delivery Devices and Accessories, is indicated for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an endoscope, in contact and non-contact with tissue, with or without a hand piece, in the following indications: Dermatology and Plastic Surgery Dermatologic and Plastic Surgery of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasias [facial, leg] and 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. Gastroenterological/Gastrointestinal Surgery Gastroenterologic surgery of soft tissue, including: cholecystectomy, lysis of adhesions, appendectorny, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benion and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophaqitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions. colorectal cancer, qastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease. General Surgery General surgery of soft tissues, including; skin incision. tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, and tissue ablations; removal of benign and malignant lesions; mastectomy, hepatectomy, pancreatectomy, splenectomy, thyroidectomy, parathyroidectomy, herniorrhaphy, tonsillectomy, lymphadenectomy, partial nephrectomy, pilonidal cystectomy, resection of lipoma, pelvic adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilonidal cyst removal and repair, debridement of statis ulcer, biopsy, appendectomy, pylorostenotomy, removal of polyps of the sigmoid colon, lysis of adhesions, cholecystectory. Genitourinary Surgery/Urology Genitourinary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors; superficial urinary bladder tumors; invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions. Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy. Gynecological Surgery Gynecological surgery of soft tissue, including condyloma acuminata. Lithotripsy and Percutaneous Urinary Lithotripsy Lithotripsy and percutaneous urinary lithotripsy, including: fragmentation of urinary calculi, fragmentation of calculi in the ureter and ureteropelvic junction, fragmentation of kidney calculi, fragmentation of urethral calculi and treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed. Lumbar Discectomy Lumbar discectomy in soft, cartilaginous and bony tissue, including: vaporization of the L.4-5 and L.5-S1 lumbar discs of the vertebral spine; open, percutaneous and endoscopic spine procedures; foraminotomy. Orthopedic Surgery Orthopedic surgery in soft and cartilaginous tissue in small and large joints (excluding the spine), including: knee meniscectomy, knee synovectomy, chondrornalacia and tears, loose body debridement, lateral retinacular release, plica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridement of inflamed synovial tissue, loose body debridement, capsulectomy in the knee, chondroplasty in the knee, chondromalacia ablation. Otorhinolaryrigological (ENT) Surgery Otorhinolaryrigological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectomy), dacryocystorhinostomy (DCR), ethmoidectorny, polypectomy, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty. Pulmonary Surgery Open and endoscopic pulmonary surgery. The Profile 3000 Laser System, and Delivery Devices and Accessories, is indicated for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Aesthetic Surgery Skin resurfacing and treatment of wrinkles. Dermatology & Plastic Surgery Indications include, epidermal nevi, telangietasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers. Gastroenterology General Surgery The Erbium:YAG laser is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, tissue ablation and/or vessel coagulation. Genitourinary/Urology Gynecology Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma. Ophthalmology Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy. Oral/Maxillofacial Otorhinolaryrigological (ENT) Surgery Podiatry Indications include warts, plantar verruae, large mosaic verrucae and matrixectomy. Pulmonary Surgery Thoracic Surgery

Device Story

Profile 2000 and 3000 are laser surgical systems emitting 2.01 µm and 2.94 µm wavelengths respectively. System comprises console, internal computer, control panel, display, fiber optic delivery system, and footswitch. Operated by physicians in clinical/surgical settings. Laser energy delivered via contact or non-contact modes to target tissues for incision, excision, ablation, vaporization, and coagulation. Internal computer manages system parameters including power output, repetition rate, and pulse duration. Output allows precise tissue removal or modification, facilitating various surgical procedures and aesthetic skin resurfacing. Benefits include controlled tissue interaction, reduced bleeding via hemostasis, and versatility across multiple surgical disciplines.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, functional features, and indications for use compared to legally marketed predicate devices.

Technological Characteristics

Laser surgical systems; Profile 2000 (2.01 µm wavelength) and Profile 3000 (2.94 µm wavelength). Includes system console, internal computer, control panel, display, fiber optic delivery system, and footswitch. Operates via laser energy emission for tissue interaction. Class II device.

Indications for Use

Indicated for incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft, mucosal, fatty, cartilaginous, and bony tissues across various surgical specialties including dermatology, plastic, gastrointestinal, general, genitourinary, gynecological, orthopedic, ENT, pulmonary, thoracic, and oral/maxillofacial surgery, as well as lithotripsy and skin resurfacing. Applicable to adult and pediatric populations depending on the specific surgical procedure.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Trimedyne Holmium Laser System
• Surgical Laser Technologies LaserPro CTH Holmium Laser System
• Lumenis VersaPulse Holmium and Dual Wavelength Surgical Lasers
• New Star Holmium Laser System
• Erbium 2000 Laser Family
• FutureLase 3000/3002 Erbium Laser System
• Schwartz Electro-Optics CLR 2940 Erbium CrystaLase
• Laserscope VELA Erbium:YAG Laser System

Submission Summary (Full Text)

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MAR 2 9 2004

.

K 040005

# Attachment IV

# 510(k) Summary

| Submitter: | Sciton, Inc. |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 845 Commercial Street, Palo Alto, CA 94303 |
| Phone: | [phone] |
| Fax : | [phone] |
| Contact Person: | Jay M. Patel, Director of Regulatory Affairs |
| Date Prepared: | March 23, 2003 |
| Device Trade Name: | Profile 2000 and Profile 3000 Laser Systems, and Delivery<br>Devices and Accessories |
| Common Name: | Laser Powered Surgical Device (and Accessories) |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Legally Marketed<br>Predicate Device: | Profile 2000 Equivalent<br>Trimedyne Holmium Laser System<br>Surgical Laser Technologies LaserPro CTH Holmium<br>Laser System<br>Lumenis VersaPulse Holmium and Dual Wavelength<br>Surgical Lasers & Delivery Devices with Accessories<br>New Star Holmium Laser System |
| | Profile 3000 Equivalent<br>Erbium 2000 Laser Family<br>FutureLase 3000/3002 Erbium Laser System<br>Schwartz Electro-Optics CLR 2940 Erbium CrystaLase<br>Laserscope VELA Erbium:YAG Laser System and<br>Accessories |
| Description of<br>Profile EV Laser System: | The Profile 2000 and Profile 3000 emits laser energy with<br>wavelength of 2.01 µm and 2.94 µm respectively.<br>The laser consists of a system console, internal computer,<br>control panel and display, and a fiber optic delivery system<br>and footswitch. |
| Intended Use: | The Profile 2000 Laser System, and Delivery Devices and<br>Accessories, is indicated for incision, excision, resection,<br>ablation, vaporization, coagulation and hemostasis, with or<br>without an endoscope, in contact and non-contact with |

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tissue, with or without a hand piece, in the following indications:

## Dermatology and Plastic Surgery

Dermatologic and Plastic Surgery of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasias [facial, leg] and 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.

### Gastroenterological/Gastrointestinal Surgery

Gastroenterologic surgery of soft tissue, including: cholecystectomy, lysis of adhesions, appendectorny, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benion and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophaqitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions. colorectal cancer, qastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.

## General Surgery

General surgery of soft tissues, including; skin incision. tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, and tissue ablations; removal of benign and malignant lesions; mastectomy, hepatectomy, pancreatectomy, splenectomy, thyroidectomy, parathyroidectomy, herniorrhaphy, tonsillectomy, lymphadenectomy, partial nephrectomy, pilonidal cystectomy, resection of lipoma, pelvic adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilonidal cyst removal and repair, debridement of statis ulcer, biopsy, appendectomy, pylorostenotomy, removal of polyps of the sigmoid colon, lysis of adhesions, cholecystectory.

## Genitourinary Surgery/Urology

Genitourinary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors; superficial urinary bladder tumors; invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions. Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and

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resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy.

## Gynecological Surgery

Gynecological surgery of soft tissue, including condyloma acuminata.

Lithotripsy and Percutaneous Urinary Lithotripsy Lithotripsy and percutaneous urinary lithotripsy, including: fragmentation of urinary calculi, fragmentation of calculi in the ureter and ureteropelvic junction, fragmentation of kidney calculi, fragmentation of urethral calculi and treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed.

## Lumbar Discectomy

Lumbar discectomy in soft, cartilaginous and bony tissue, including: vaporization of the L.4-5 and L.5-S1 lumbar discs of the vertebral spine; open, percutaneous and endoscopic spine procedures; foraminotomy.

## Orthopedic Surgery

Orthopedic surgery in soft and cartilaginous tissue in small and large joints (excluding the spine), including: knee meniscectomy, knee synovectomy, chondrornalacia and tears, loose body debridement, lateral retinacular release, plica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridement of inflamed synovial tissue, loose body debridement, capsulectomy in the knee, chondroplasty in the knee, chondromalacia ablation.

## Otorhinolaryrigological (ENT) Surgery

Otorhinolaryrigological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectomy), dacryocystorhinostomy (DCR), ethmoidectorny, polypectomy, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty.

Pulmonary Surgery Open and endoscopic pulmonary surgery.

The Profile 3000 Laser System, and Delivery Devices and Accessories, is indicated for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or

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fragments, mucous membrane, lymph vessels and nodes, organs and glands.

## Aesthetic Surgery

Skin resurfacing and treatment of wrinkles.

## Dermatology & Plastic Surgery

Indications include, epidermal nevi, telangietasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers.

## Gastroenterology

## General Surgery

The Erbium:YAG laser is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, tissue ablation and/or vessel coagulation.

## Genitourinary/Urology

## Gynecology

Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.

Ophthalmology Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.

## Oral/Maxillofacial

## Otorhinolaryrigological (ENT) Surgery

## Podiatry

Indications include warts, plantar verruae, large mosaic verrucae and matrixectomy.

## Pulmonary Surgery

## Thoracic Surgery

Rationale for Substantial Equivalence:

The Profile 2000 and Profile 3000 Laser Systems and Delivery Devices and Accessories share intended use, indications for use, similar design features (including wavelength, power supply, cooling and control system). functional features (including power output, repetition rate

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| | | and pulse duration), and is therefore substantially<br>equivalent to above legally marketed predicate devices. |
|-----------------------------------------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and Effectiveness<br>Information | | The indications for use are based upon the indications for<br>use for predicate systems. Technologically, the Profile<br>2000 and Profile 3000 Laser Systems, and Delivery<br>Devices and Accessories are substantially equivalent to<br>the listed predicate devices. Therefore, the risks and<br>benefits for the Profile 2000 and Profile 3000 Laser<br>Systems, and Delivery Devices and Accessories are<br>comparable to the predicate devices. |
| Conclusion | | The Profile 2000 and Profile 3000 Laser Systems, and<br>Delivery Devices and Accessories, share similar<br>indications for use, design features, and similar functional<br>features as, and therefore are substantially equivalent to,<br>the currently marketed predicate surgical lasers, delivery<br>devices and accessories. |

1000 - 1000

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human figures, possibly representing health, family, and community. The emblem is designed with flowing lines to create a sense of movement and unity.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2004

Mr. Jay M. Patel Director of Regulatory Affairs Sciton, Inc. 845 Commercial Street Palo Alto. California 94303

Re: K040005 Trade/Device Name: Profile 2000 and Profile 3000 Laser Systems, and Delivery Devices and Accessories Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 30, 2003 Received: January 7, 2004

Dear Mr. Patel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Jay M. Patel

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

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

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## Attachment III

## Statement of Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Profile 2000 and Profile 3000 Laser Systems, and Delivery Devices Device Name: _________________________________________________________________________________________________________________________________________________________________ and Accessories

Indications for Use:

The Profile 2000 Laser System, and Delivery Devices and Accessories, is incieated for incision, excision, The Profite 2000 Laser System, and Delivery Delivery Devece without an endoscope, in contact and room ontact with tissue, with or without a hand piece, in the following indications:

## Dermatology and Plastic Surgery

Dermatologic and Plastic Surgery of soft, mucosal, fatty and cartilaginous tissue, in thereoutic plastic Dermatological and Plastic Surgely of Sol, macosal, including scars, tettoo removal, vascular
therapeutic dermatological and aesthetic surgical procedures, including seconomi therapedite dermatological and aestrests surgious proceeding (facial, leg] and rosacea), coms.
lesions (including port wine stains, hemangioma, telangiectasias (facial, cont lesions (ficiouning por wire stams, nemongloma, thengrounds tissue, plantar warts, periungual and subungual warts, debridement of decubitus ulcer, skin tag vaporization.

## Gastroenterological/Gastrointestinal Surgery

Gastroenterologic surgery of soft tissue, including: cholecysted on of significansis appendectorny, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid color, gall bladder biopsy, pylorosteriotony, belligh and malignant neoplasm, polypes collits, ulcers, angiodysplassia.
calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyp carculi, billarylblie doct calcul, beingh and nealignally porporation in and and allest, ducer, ducer, ducer, ducer, and class and nemormolds, values, esophageal cancer, gastritis, bleeting gumrs, pancealitis, vascular
non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleebing turnsesse molleding uncer, gastro erodono, establish Judinestas of the Osler-Weber-Rendu disease.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21CFR801) | OR Over-The-Counter Use |
|------------------------------------|-------------------------|
|------------------------------------|-------------------------|

*Miriam C. Provont*
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 3

| 510(k) Number | K040005 |
|---------------|---------|
|---------------|---------|

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### General Surgery

General surgery of soft tissues, including; skin incision, tissue dissection, excision of exemal turnors and firens and firens and firens and firens and firens a General surgely of son ilssues, including, akki meason, associations, and tissue ablations, and tissue ableting and lealons, complete of patilar reseason or member of pepatectorny, pancreationy, spienectomy, particl removal of beth and mongham lobemiormaphy, tonsillectorny, lymphadenectorny, patial thyroldectorny, parathyroldectorly, nemothlaphy, tonsmectory, the program of decubitus nephectority, pilonidal cystexonly, rooosler or spair, debridement of statis ulcer, biopsy, bicer, nemormolas, phornations, removal of polyps of the sigmoid colon, lysis of adhesions, cholecystectorny.

#### Genitourinary Surgery/Urology

Genitourinary surgery of soft tissue, including; treatment of bladder, und und secule heaveniems Genitountary bladder turnors; invasive bladder carcinomas; urethral and penile hennangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder nectors; lease plant urelifal strictures, lesions of the external generalia, or the prostate, laser able for Efficultures in and resection of prostate, biadel mobilities and excision for treatment of benign prostatic hypertrophy.

### Gynecological Surgery

Gynecological surgery of soft tissue, including condyloma acuminata.

### Lithotripsy and Percutaneous Urinary Lithotripsy

Lithotripsy and perculaneous urinary lithotripsy, including; fragmentation of kirker of kirker on Cithollipsy and percularieous unlary illusting, fraguitis, fragmentation of kidney calculi, tragmentation of calculi in the dreler and dicital impacted fragments of steinstrasse when guide wires cannot be passed.

### Lumbar Discectomy

Lumbar discectorny in soft, cartilaginous and bony tissue, including: vaporization of the advances Eurnbar disocctorry in Gott Garalagine open, percutaneous and endoscopic spine procedures; foraminotomy.

### Orthopedic Surgery

Othopedic surgery in soft and cartilaginous tissue in small and large joints (excluding the spire). Officipedic surgery in son canaginous in still and tears, loose body debridement.
including: knee meniscectorny, knee synovectomy, chondromalacia and tearing of Including. Kree menisceclonity, knee synoven and tendon release, contouring and sculpting of lateral relifacular release, plica removal, ligatheri, and tendon rolouse, considerative, in the knee, chondroplasty in the knee, chondromalacia ablation.

#### Otorhinolaryrigological (ENT) Surgery

Otominolaryngological (ENT) surgery in soft, mucosal, cartilaginous and borny tissue, including, Olominolarynguogical (ENT) surgery in son, moosed, dertingmosphy, from the procedures (e.g. turningplash, endosinos surgery, funkalonal ondosophe simal birgory, polypectomy, maxiltary antrotomy, tarbinectority), but your routinationy, hereditary hemorrhagic telangectasia, septoplasty.

### Pulmonary Surgery

Open and endoscopic pulmonary surgery.

The Profile 3000 Laser System, and Delivery Devices and Accessories, is indicated for use in aurgical The Fronte Jour Laser System, and Delivery De need and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, not deads resultacing. Sont insue muddes min, coosetancede liberty vessels and nodes, organs and glands.

### Aesthetic Surgery

Skin resurfacing and treatment of wrinkles.

### Dermatology & Plastic Surgery

Uermatology & Elashc Suggel
Indications include, epidermal nevi, telangietasia, spider veilini, keloids, verrucae, skin the transmont and the revision, debulking benign tumors, decubitis ulcers,

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## Gastroenterology

### General Surgery

General Surgery
The Erbium,YAG laser is intended for the surgical incision, vaportization argicion of soft The Erbitin', FAG laser is internet for surger resion existed dissection, excision, excision of external tissue dunny any general strigery application where bail industry, issue ablation and/or vessel coagulation.

### Genitourinary/Urology

### Gynecology

Gynecology
Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.

### Ophthalmology

Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.

### Oral/Maxillofacial

### Otorhinolaryrigological (ENT) Surgery

#### Podiatry

Indications include warts, plantar verruae, large mosaic verrucae and matrixectorny.

### Pulmonary Surgery

Thoracic Surgery