WATERLASE IPLUS S

K141975 · Biolase, Inc. · GEX · Mar 5, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K141975
• Device Name: WATERLASE IPLUS S
• Applicant: Biolase, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Waterlase iPlus S is intended for use as a laser surgical instrument in the following medical specialties requiring the incision, excision, vaporization, ablation and coagulation of soft tissue: Dermatology/Plastic Surgery, Ear, Nose and Throat (ENT), Gastroenterology, General Surgery, Genitourinary/Urology, Gynecology, Ophthalmology, Oral/Maxillofacial Surgery, Podiatry, Pulmonary Surgery and Thoracic Surgery. It is indicated for the following expanded Indications for Use: Dermatology/Plastic Surgery: The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking of benign tumors, decubitis ulcers, cysts, diagnostic biopsy and skin resurfacing and treatment of wrinkles. Ear, Nose and Throat (ENT): The following indications can be used with the Angled or Straight Handpieces: ENT surgery in soft, mucosal, cartilaginous and bony tissue, including endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectomy), dacryocystorhinostomy (DCR), ethmoidectomy, polypectomy, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangiectasias, septoplasty, lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia. Gastroenterology: The following indications can be used with the Angled or Straight Handpieces: Gastroenterologic surgery of soft tissue, including cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, 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 and telangiectasias of the Osler-Weber-Rendu disease. General Surgery: The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated. Genitourinary/Urology: The following indications are used with the Angled Handpieces: 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, urethra and anus, penis, scrotum, (includes condyloma acuminate, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon, bladder neck obstructions. The following indications are used with the Straight Handpieces: 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. Gynecology: The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma. Ophthalmology: The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: General ophthalmic soft tissue surgical indications such as: Incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit. Oral/Maxillofacial Surgery: The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Oral/dental procedures for incision, excision, ablation, vaporization and hemostasis of soft tissue during gingivoplasties, gingivectomies, frenectomies, benign and malignant lesion removal, biopsies, leukoplakia and fibrotomy. Podiatry: The following indications can be used with the Angled or Contra-Angled Handpieces: Warts, plantar verrucae, large mosaic verrucae and matrixectomy. Pulmonary Surgery: The following indications can be used with the Angled or Straight Handpieces: Open and endoscopic pulmonary surgery. Thoracic Surgery: The following indications can be used with the Angled or Straight Handpieces: Surgical incision/excision, vaporization and coagulation of soft tissue during any thoracic surgery.

Device Story

Waterlase iPlus S is an Er,Cr:YSGG solid-state laser system (2.78 µm wavelength); delivers optical energy combined with atomized water droplets for soft tissue surgery. System includes cabinet housing power supply, cooling system, micro-controller, laser, foot switch, and fiber optic handpiece with various tips. Used in clinical settings by physicians for incision, excision, ablation, vaporization, coagulation, and hemostasis. Clinician controls laser parameters; water spray provides cooling and hydration. Output allows precise tissue removal and vessel coagulation; aids in surgical procedures across multiple specialties. Benefits include reduced thermal damage and controlled tissue interaction.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and laser safety (IEC 60825-1, IEC 60601-2-22). Software verification and validation performed for GUI modifications.

Technological Characteristics

Er,Cr:YSGG solid-state laser; 2.78 µm wavelength; Class IV laser; 10W max output; pulsed free-running mode; water-cooled; fiber optic delivery. Materials: medical grade plastics, steel, stainless steel, aluminum, brass. Connectivity: standalone. Software: GUI-based control.

Indications for Use

Indicated for patients requiring soft tissue incision, excision, vaporization, ablation, or coagulation across multiple surgical specialties including Dermatology, ENT, Gastroenterology, General Surgery, Urology, Gynecology, Ophthalmology, Oral/Maxillofacial, Podiatry, Pulmonary, and Thoracic surgery. Applicable to various benign/malignant lesions, tumors, and specific conditions like BPH, CIN, and ocular tissue procedures.

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

• Oculase MD (K052354)
• Waterlase MD Derm (K071734)
• Profile Multi-Platform System (K060033)
• Laserscope VELA Erbium:YAG Laser System and Accessories (K971843)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 5, 2015

Biolase Incorporated Ms. Colleen Boswell Vice President of Regulatory Affairs and Quality Assurance 4 Cromwell Irvine, California 92618

Re: K141975 Trade/Device Name: Waterlase iPlus S Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: February 4, 2015 Received: February 6, 2015

Dear Ms. Boswell:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K141975

Device Name Waterlase iPlus S

#### Indications for Use (Describe)

The Waterlase iPlus S is intended for use as a laser surgical instrument in the following medical specialties requiring the incision, excision, vaporization, ablation of soft tissue: Dermatology/Plastic Surgery, Ear, Nose and Throat (ENT), Gastroenterology, General Surgery, Genitourinary/Urology, Gynecology, Ophthalmology, Oral/ Maxillofacial Surgery, Podiatry, Pulmonary Surgery and Thoracic Surgery. It is indicated for the following expanded Indications for Use:

#### Dermatology/Plastic Surgery:

The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Incision, excision, ablation, vaporization of dermatologic tissues including epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, keratoses, scar revision, debulking of begin tumors, decubitis ulcers, cysts, diagnostic biopsy and skin resurfacing and treatment of wrinkles.

#### Ear, Nose and Throat (ENT):

The following indications can be used with the Angled or Straight Handpieces:

ENT surgery in soft, mucosal, cartilaginous and bony tissue, including endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectomy), dacryocystorhinostomy (DCR), ethmoidectomy, polypectomy, maxillary antrotomy, frontal sinusotomy, hereditary, hereditary hemorrhagic telangiectasias, septoplasty, lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia.

#### Gastroenterology:

The following indications can be used with the Angled or Straight Handpieces:

Gastroenterologic surgery of soft tissue, including cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, 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, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias of the Osler-Weber-Rendu disease.

#### General Surgery:

The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Incision, excision, vaporization of soft tissue during general surgical applications where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.

#### Genitourinary/Urology:

The following indications are used with the Angled Handpieces:

Genitourinary surgery of soft tissue, including treatment of bladder, urethral tumors, superficial urinary bladder tumors, invasive bladder carcinomas, urethral and penile hemangioma, urethral strictures, lesions of the external genitalia, urethra and anus, penis, scrotum, (includes condyloma acuminate, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon, bladder neck obstructions.

The following indications are used with the Straight Handpieces:

Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation and

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

## Gynecology:

The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.

## Ophthalmology:

The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: General ophthalmic soft tissue surgical indications such as: Incision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit.

## Oral/Maxillofacial Surgery:

The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Oral/dental procedures for incision, ablation, vaporization and hemostasis of soft tissue during gingivoplasties. gingivectomies, frenectomies, benign and malignant lesion removal, biopsies, leukoplakia and fibrotomy.

Podiatry:

The following indications can be used with the Angled or Contra-Angled Handpieces: Warts, plantar verrucae, large mosaic verrucae and matrixectomy.

Pulmonary Surgery:

The following indications can be used with the Angled or Straight Handpieces: Open and endoscopic pulmonary surgery.

Thoracic Surgery:

The following indications can be used with the Angled or Straight Handpieces: Surgical incision/excision, vaporization and coagulation of soft tissue during any thoracic surgery.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for BIOLASE, Inc. The logo consists of the word "BIOLASE" in large, blue, sans-serif font, followed by a vertical line. To the right of the line is the text "BIOLASE, Inc." followed by the address "4 Cromwell, Irvine, CA 92618" in a smaller, gray font.

## 510(k) Summary

#### Submitter:

Biolase, Inc. 4 Cromwell Irvine, California 92618 [phone] - Phone [phone] - Facsimile Alicia Mszyca - Contact Person

Date Summary Prepared: February 2015

- Trade Name Waterlase iPlus S ●
- Common Name - Er,Cr:YSGG Laser
- Classification Name - Laser surgical instrument for use in general and plastic surgery and in dermatology, per 21 CFR 878.4810
- . Product Code - GEX

Devices for Which Substantial Equivalence is Claimed:

- Oculase MD, Biolase, Inc., K052354 ●
- Waterlase MD Derm, Biolase, Inc., K071734
- Profile Multi-Platform System, Sciton, Inc., K060033
- Laserscope VELA Erbium:YAG Laser System and Accessories, Laserscope, K971843

#### Device Description

The Waterlase iPlus S system is an erbium, chromium, yttrium, scandium, garnet (ER,CR:YSGG) solid state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2.78 µm (2780 nm). The laser consists of a cabinet which houses the power supply, the cooling system, micro-controller, laser, foot switch, and fiber optic for delivery of laser energy with the fiber optic handpiece. Various handpiece and tip types are available depending upon the clinician's preference for the different applications. The Waterlase iPlus S system utilizes direct laser energy either with or without water for cooling and hydration to perform soft tissue incision, resection, ablation, vaporization, coagulation and hemostasis.

#### Statement of Intended Use

The Waterlase iPlus S is intended for use as a laser surgical instrument in the following medical specialties requiring the incision, excision, vaporization, ablation and coagulation of soft tissue: Dermatology/Plastic Surgery, Ear, Nose and Throat (ENT), Gastroenterology, General Surgery, Genitourinary/Urology, Gynecology, Ophthalmology, Oral/Maxillofacial Surgery, Podiatry, Pulmonary Surgery and Thoracic Surgery. It is indicated for the following expanded Indications for Use:

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## Dermatology/Plastic Surgery:

## The following indications can be used with the Angled, Contra-Angled or Straight Handpieces:

Incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, keratoses, scar revision, debulking of begin tumors, decubitis ulcers, cysts, diagnostic biopsy and skin resurfacing and treatment of wrinkles.

#### Ear, Nose and Throat (ENT):

#### The following indications can be used with the Angled or Straight Handpieces:

ENT surgery in soft, mucosal, cartilaginous and bony tissue, including endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectomy), dacryocystorhinostomy (DCR), ethmoidectomy, polypectomy, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangiectasias, septoplasty, lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia.

## Gastroenterology:

## The following indications can be used with the Angled or Straight Handpieces:

Gastroenterologic surgery of soft tissue, including cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, 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, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias and telangiectasias of the Osler-Weber-Rendu disease.

#### General Surgery:

#### The following indications can be used with the Angled, Contra-Angled or Straight Handpieces:

Incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.

#### Genitourinary/Urology:

#### The following indications are used with the Angled Handpieces:

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, urethra and anus, penis, scrotum, (includes condyloma acuminate, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon, bladder neck obstructions.

#### The following indications are used with the Straight Handpieces:

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.

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## Gynecology:

The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.

## Ophthalmology:

The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: General ophthalmic soft tissue surgical indications such as: Incision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit.

## Oral/Maxillofacial Surgery:

The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Oral/dental procedures for incision, excision, ablation, vaporization and hemostasis of soft tissue during gingivoplasties, gingivectomies, frenectomies, benign and malignant lesion removal, biopsies, leukoplakia and fibrotomy.

## Podiatry:

The following indications can be used with the Angled or Contra-Angled Handpieces: Warts, plantar verrucae, large mosaic verrucae and matrixectomy.

## Pulmonary Surgery:

The following indications can be used with the Angled or Straight Handpieces: Open and endoscopic pulmonary surgery.

#### Thoracic Surgery:

## The following indications can be used with the Angled or Straight Handpieces:

Surgical incision/excision, vaporization and coagulation of soft tissue during any thoracic surgery.

Summary of Technological Characteristics

Refer to the Table on the following pages.

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| Descriptive<br>Information | Waterlase iPlus S | Oculase MD<br>(K052354) | Waterlase MD<br>Derm<br>(K071734) | Profile Multi-<br>Platform System<br>(K060033) | Laserscope VELA<br>(K971843) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Biolase, Inc. | Biolase, Inc. | Biolase, Inc. | Sciton, Inc. | Laserscope |
| Indications for<br>Use | The Waterlase iPlus S is<br>intended for use as a<br>laser surgical instrument<br>in the following medical<br>specialties requiring the<br>incision, excision,<br>vaporization, ablation<br>and coagulation of soft<br>tissue:<br>Dermatology/Plastic<br>Surgery, Ear, Nose and<br>Throat (ENT),<br>Gastroenterology,<br>General Surgery,<br>Genitourinary/Urology,<br>Gynecology,<br>Ophthalmology,<br>Oral/Maxillofacial<br>Surgery, Podiatry,<br>Pulmonary Surgery and<br>Thoracic Surgery. It is<br>indicated for the<br>following expanded<br>Indications for Use:<br><br>Dermatology/Plastic<br>Surgery: | The Oculase MD<br>may be indicated for<br>general ophthalmic<br>soft tissue surgical<br>indications such as:<br>Incision, excision,<br>vaporization and<br>coagulation of<br>ocular tissue and<br>tissue surrounding<br>the eye and orbit. | Use of the device<br>is indicated for<br>the incision,<br>excision, ablation,<br>vaporization and<br>coagulation of<br>dermatologic<br>tissues including<br>epidermal nevi,<br>cheilitis, keloids,<br>verrucae, skin<br>tags, keratosis,<br>scar revision,<br>debulking of<br>tumors, cysts,<br>diagnostic biopsy<br>and skin<br>resurfacing.<br><br>Use of the device<br>is further<br>indicated for the<br>incision, excision,<br>vaporization and<br>coagulation of<br>soft tissue during<br>general surgical<br>applications | 2940nm Indications<br>for Use:<br>The Profile Multi-<br>Platform and<br>Accessories are<br>designed for use in<br>surgical applications<br>requiring the<br>excision, incision,<br>ablation,<br>vaporization, and<br>coagulation of soft<br>tissue, and for skin<br>resurfacing. Soft<br>tissue includes skin,<br>subcutaneous<br>tissue, striated and<br>smooth tissue,<br>muscle, cartilage,<br>cartilage meniscus,<br>calculi or fragments,<br>mucous membrane,<br>lymph vessels and<br>nodes, organs and<br>glands. Surgical<br>specialties and<br>applications include<br>general surgery. | The Laserscope<br>VELA Erbium:YAG<br>Laser System and<br>Accessories are<br>intended for the<br>surgical<br>incision/excision,<br>vaporization and<br>coagulation of soft<br>tissue. All soft<br>tissue is included,<br>such as skin,<br>subcutaneous<br>tissue, striated<br>and smooth<br>tissue, muscle,<br>cartilage<br>meniscus, mucous<br>membrane, lymph<br>vessels and nodes,<br>organs and glands.<br>Dermatology/<br>Plastic Surgery:<br>Indications<br>include, epidermal<br>nevi,<br>telangiectasia,<br>spider veins. |
| Descriptive<br>Information | Waterlase iPlus S | Oculase MD<br>(K052354) | Waterlase MD<br>Derm<br>(K071734) | Profile Multi-<br>Platform System<br>(K060033) | Laserscope VELA<br>(K971843) |
| | Incision, excision,<br>ablation, vaporization<br>and coagulation of<br>dermatologic tissues<br>including epidermal<br>nevi, telangiectasia,<br>spider veins, actinic<br>cheilitis, keloids,<br>verrucae, skin tags, anal<br>tags, keratoses, scar<br>revision, debulking of<br>benign tumors,<br>decubitis ulcers, cysts,<br>diagnostic biopsy and<br>skin resurfacing and<br>treatment of wrinkles. | | where skin<br>incision, tissue<br>dissection,<br>excision of<br>external tumors<br>and lesions,<br>complete or<br>partial resection<br>of internal organs,<br>tumors and<br>lesions, tissue<br>ablation and/or<br>vessel coagulation<br>may be indicated. | plastic surgery,<br>aesthetic surgery,<br>dermatology,<br>urology, gynecology,<br>genitourinary, ENT,<br>pulmonary, surgery,<br>thoracic surgery,<br>podiatry, oral &<br>maxillofacial<br>surgery,<br>ophthalmology<br>(including<br>oculoplasty), small<br>and large joint<br>arthroscopy, micro-<br>discectomies and<br>endoscopic<br>procedures. | actinic cheilitis,<br>keloids, verrucae,<br>skin tags, anal<br>tags, keratoses,<br>scar revision,<br>debulking benign<br>tumors, decubitis<br>ulcers and skin<br>resurfacing.<br>General Surgery<br>The Erbium:YAG<br>laser is intended<br>for the surgical<br>incision/excision,<br>vaporization and<br>coagulation of soft<br>tissue during any<br>general surgery<br>application where<br>skin incision,<br>tissue dissection,<br>excision of<br>external tumors<br>and lesions,<br>complete or<br>partial resection<br>of internal organs,<br>tumors and<br>lesions tissue |
| | Ear, Nose and Throat<br>(ENT):<br>ENT surgery in soft,<br>mucosal, cartilaginous<br>and bony tissue,<br>including endosinus<br>surgery, functional<br>endoscopic sinus<br>surgery, turbinate<br>procedures (e.g.<br>turbinoplasty,<br>turbinectomy) | | | <b>Aesthetic Surgery</b><br>Skin resurfacing and<br>treatment of<br>wrinkles.<br><b>Dermatology &amp;<br/>Plastic Surgery</b><br>Indications include,<br>epidermal nevi,<br>telangiectasia,<br>spider veins, actinic<br>cheilitis, keloids | |
| Descriptive<br>Information | Waterlase iPlus S | Oculase MD<br>(K052354) | Waterlase MD<br>Derm<br>(K071734) | Profile Multi-<br>Platform System<br>(K060033) | Laserscope VELA<br>(K971843) |
| | dacryocystorhinostomy<br>(DCR), ethmoidectomy, | | | verrucae, skin tags, | ablation and/or |
| | polypectomy, maxillary | | | anal tags, keratoses, | vessel coagulation |
| | antrotomy, frontal | | | scar revision, | may be indicated. |
| | sinusotomy, | | | debulking benign | Genitourinary: |
| | sphenoidotomy, | | | tumors, decubitis | Indications |
| | hereditary hemorrhagic | | | ulcers. It is also | include lesions of |
| | telangiectasias, | | | used for laser | the external |
| | septoplasty, lesions, | | | assisted site | genitalia, urethra |
| | polyps, cysts, | | | preparation for hair | and anus, penis, |
| | hyperkeratosis, excision | | | transplantation. | scrotum and |
| | of carcinogenic tissue, | | | Gastroenterology | urethra (includes |
| | oral leukoplakia. | | | Gastroenterologic | condyloma |
| |…