(227 days)
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.
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.
The provided document is a 510(k) premarket notification for the "Waterlase iPlus S" laser surgical instrument. It details the device's intended use and provides a comparison to predicate devices, but it does not contain acceptance criteria or a study proving device performance in the way typically associated with clinical or standalone performance studies for AI/CAD devices.
The document states:
- "No other performance testing was conducted since the purpose of this 510(k) is to only expand the Indications for Use from the previous 510(k) clearances under 510(k) Nos.: K101658 and K122368."
- "Clinical testing was not conducted on this device."
- The conclusion of substantial equivalence is based on "comparison of the Waterlase iPlus S with the same device, Waterlase iPlus, Profile Multi-Platform System and Laserscope VELA previously cleared by the FDA".
Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence based on expanded indications for use and technical similarity to previously cleared predicate devices, rather than new performance data.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central image.
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
{1}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
{3}------------------------------------------------
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 (949) 226-8470 - Phone (949) 273-6688 - 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:
{5}------------------------------------------------
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.
{6}------------------------------------------------
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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| DescriptiveInformation | Waterlase iPlus S | Oculase MD(K052354) | Waterlase MDDerm(K071734) | Profile Multi-Platform System(K060033) | Laserscope VELA(K971843) |
|---|---|---|---|---|---|
| Company | Biolase, Inc. | Biolase, Inc. | Biolase, Inc. | Sciton, Inc. | Laserscope |
| Indications forUse | The Waterlase iPlus S isintended for use as alaser surgical instrumentin the following medicalspecialties requiring theincision, excision,vaporization, ablationand coagulation of softtissue:Dermatology/PlasticSurgery, Ear, Nose andThroat (ENT),Gastroenterology,General Surgery,Genitourinary/Urology,Gynecology,Ophthalmology,Oral/MaxillofacialSurgery, Podiatry,Pulmonary Surgery andThoracic Surgery. It isindicated for thefollowing expandedIndications for Use:Dermatology/PlasticSurgery: | The Oculase MDmay be indicated forgeneral ophthalmicsoft tissue surgicalindications such as:Incision, excision,vaporization andcoagulation ofocular tissue andtissue surroundingthe eye and orbit. | Use of the deviceis indicated forthe incision,excision, ablation,vaporization andcoagulation ofdermatologictissues includingepidermal nevi,cheilitis, keloids,verrucae, skintags, keratosis,scar revision,debulking oftumors, cysts,diagnostic biopsyand skinresurfacing.Use of the deviceis furtherindicated for theincision, excision,vaporization andcoagulation ofsoft tissue duringgeneral surgicalapplications | 2940nm Indicationsfor Use:The Profile Multi-Platform andAccessories aredesigned for use insurgical applicationsrequiring theexcision, incision,ablation,vaporization, andcoagulation of softtissue, and for skinresurfacing. Softtissue includes skin,subcutaneoustissue, striated andsmooth tissue,muscle, cartilage,cartilage meniscus,calculi or fragments,mucous membrane,lymph vessels andnodes, organs andglands. Surgicalspecialties andapplications includegeneral surgery. | The LaserscopeVELA Erbium:YAGLaser System andAccessories areintended for thesurgicalincision/excision,vaporization andcoagulation of softtissue. All softtissue is included,such as skin,subcutaneoustissue, striatedand smoothtissue, muscle,cartilagemeniscus, mucousmembrane, lymphvessels and nodes,organs and glands.Dermatology/Plastic Surgery:Indicationsinclude, epidermalnevi,telangiectasia,spider veins. |
| DescriptiveInformation | Waterlase iPlus S | Oculase MD(K052354) | Waterlase MDDerm(K071734) | Profile Multi-Platform System(K060033) | Laserscope VELA(K971843) |
| Incision, excision,ablation, vaporizationand coagulation ofdermatologic tissuesincluding epidermalnevi, telangiectasia,spider veins, actiniccheilitis, keloids,verrucae, skin tags, analtags, keratoses, scarrevision, debulking ofbenign tumors,decubitis ulcers, cysts,diagnostic biopsy andskin resurfacing andtreatment of wrinkles. | where skinincision, tissuedissection,excision ofexternal tumorsand lesions,complete orpartial resectionof internal organs,tumors andlesions, tissueablation and/orvessel coagulationmay be indicated. | plastic surgery,aesthetic surgery,dermatology,urology, gynecology,genitourinary, ENT,pulmonary, surgery,thoracic surgery,podiatry, oral &maxillofacialsurgery,ophthalmology(includingoculoplasty), smalland large jointarthroscopy, micro-discectomies andendoscopicprocedures. | actinic cheilitis,keloids, verrucae,skin tags, analtags, keratoses,scar revision,debulking benigntumors, decubitisulcers and skinresurfacing.General SurgeryThe Erbium:YAGlaser is intendedfor the surgicalincision/excision,vaporization andcoagulation of softtissue during anygeneral surgeryapplication whereskin incision,tissue dissection,excision ofexternal tumorsand lesions,complete orpartial resectionof internal organs,tumors andlesions tissue | ||
| Ear, Nose and Throat(ENT):ENT surgery in soft,mucosal, cartilaginousand bony tissue,including endosinussurgery, functionalendoscopic sinussurgery, turbinateprocedures (e.g.turbinoplasty,turbinectomy) | Aesthetic SurgerySkin resurfacing andtreatment ofwrinkles.Dermatology &Plastic SurgeryIndications include,epidermal nevi,telangiectasia,spider veins, actiniccheilitis, keloids | ||||
| DescriptiveInformation | Waterlase iPlus S | Oculase MD(K052354) | Waterlase MDDerm(K071734) | Profile Multi-Platform System(K060033) | Laserscope VELA(K971843) |
| dacryocystorhinostomy(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 | |||
| surgery of soft | acuminate, giant | ||||
| Gastroenterology: | tissue, include: | perineal | |||
| Gastroenterologic | cholecystectomy, | condyloma and | |||
| surgery of soft tissue, | lysis of adhesions, | verrucous | |||
| including | appendectomy, | carcinoma), vulvar | |||
| cholecystectomy, lysis | biopsy, | lesions, polyps | |||
| of adhesions, | pylorostenotomy, | and familiar | |||
| appendectomy, biopsy, | benign and | polyps of the | |||
| pylorostenotomy, | malignant lesions, | colon. | |||
| benign and malignant | rectal polyps of | Gynecology | |||
| lesions, rectal polyps of | sigmoid colon, gall | Indications | |||
| sigmoid colon, gall | bladder calculi, | include cervical | |||
| bladder calculi, | biliary/bile duct | intraepithelial | |||
| biliary/bile duct calculi, | calculi, benign and | neoplasia (CIN), | |||
| benign and malignant | malignant | herpes simplex, | |||
| neoplasm, polyps, | neoplasm, polyps, | endometrial | |||
| neoplasm, polyps | colitis, ulcers | ||||
| DescriptiveInformation | Waterlase iPlus S | Oculase MD(K052354) | Waterlase MDDerm(K071734) | Profile Multi-Platform System(K060033) | Laserscope VELA(K971843) |
| colitis, ulcers, | angiodysplasia, | adhesions, cysts | |||
| angiodysplasia, | hemorrhoids, | and condyloma. | |||
| hemorrhoids, varices, | varices, esophagitis, | ENTIndications | |||
| esophagitis, esophageal | esophageal ulcer, | include ear, nose | |||
| ulcer, Mallory-Weiss | Mallory-Weiss tear, | and throat lesions, | |||
| tear, gastric ulcer, | gastric ulcer, | polyps, cysts, | |||
| duodenal ulcer, non- | duodenal ulcer, | hyperkeratosis, | |||
| bleeding ulcer, gastric | non-bleeding ulcer, | excision of | |||
| erosions, colorectal | gastric erosions, | carcinogenic | |||
| cancer, gastritis, | colorectal cancer, | tissue, oral | |||
| bleeding tumors, | gastritis, bleeding | leukoplakia. | |||
| pancreatitis, vascular | tumors, | Oral/Maxillofacial | |||
| malformations, | pancreatitis, | Indications | |||
| telangiectasias and | vascular | include benign | |||
| telangiectasias of the | malformations, | oral tumors, oral | |||
| Osler-Weber-Rendu | telangiectasias and | and glossal lesions | |||
| disease. | telangiectasias of | and gingivectomy. | |||
| the Osler-Weber- | Ophthalmology | ||||
| General Surgery: | Rendu disease. | Indications | |||
| Incision, excision, | General Surgery | include soft tissue | |||
| vaporization and | The Er:YAG is | surrounding the | |||
| coagulation of soft | intended for the | eye and orbit and | |||
| tissue during general | surgical | anterior | |||
| surgical applications | incision/excision, | capsulotomy. | |||
| where skin incision, | vaporization and | Podiatry | |||
| tissue dissection, | coagulation of soft | Indications | |||
| excision of external | tissue during any | include warts, | |||
| tumors and lesions, | general surgery | plantar verrucae | |||
| complete or partial | application where | ||||
| DescriptiveInformation | Waterlase iPlus S | Oculase MD(K052354) | Waterlase MDDerm(K071734) | Profile Multi-Platform System(K060033) | Laserscope VELA(K971843) |
| resection of internalorgans, tumors andlesions, tissue ablationand/or vesselcoagulation may beindicated. | skin incision, tissuedissection, excisionof external tumorsand lesions,complete or partialresection of internalorgans, tumors,tissue ablationand/or vesselcoagulation. | large mosaicverrucae andmatrixectomy. | |||
| Genitourinary/Urology:Genitourinary surgery ofsoft tissue, includingtreatment of bladder,urethral and ureteraltumors, superficialurinary bladder tumors,invasive bladdercarcinomas, urethraland penilehemangioma, urethralstrictures, lesions of theexternal genitalia,urethra and anus, penis,scrotum, (includescondyloma acuminate,giant perinealcondyloma andverrucous carcinoma),vulvar lesions, polypsand familial polyps of | Genitourinary/UrologyGenitourinarysurgery of softtissue, including:treatment ofbladder, urethraland ureteraltumors; superficialurinary bladdertumors; invasivebladder carcinomas;urethral and penilehemangioma;urethral strictures,lesions of theexternal genitalia;condylomas; | ||||
| DescriptiveInformation | Waterlase iPlus S | Oculase MD(K052354) | Waterlase MDDerm(K071734) | Profile Multi-Platform System(K060033) | Laserscope VELA(K971843) |
| the colon, bladder neckobstructions.Endoscopictransurethral incision ofprostate, bladder neckincision of the prostate,laser ablation,enucleation andresection of prostate,hemostasis,vaporization andexcision for treatmentof benign prostatichypertrophy.Gynecology:Cervical intraepithelialneoplasia (CIN), herpessimplex, endometrialadhesions, cysts andcondyloma.Ophthalmology:General ophthalmic softtissue surgicalindications such as:Incision, excision,vaporization andcoagulation of oculartissue and tissue | bladder neckobstructions.Endoscopictransurethralincision of prostate,bladder neckincision of theprostate, laserablation,enucleation andresection ofprostate,hemostasis,vaporization andexcision fortreatment of benignprostatichypertrophy.GynecologyIndications includecervicalintraepithelialneoplasia (CIN),herpes simplex,endometrialadhesions, cysts andcondyloma.Ophthalmology | ||||
| DescriptiveInformation | Waterlase iPlus S | Oculase MD(K052354) | Waterlase MDDerm(K071734) | Profile Multi-Platform System(K060033) | Laserscope VELA(K971843) |
| surrounding the eye andorbit.Oral/MaxillofacialSurgery:Oral/dental proceduresfor incision, excision,ablation, vaporizationand hemostasis of softtissue duringgingivoplasties,gingivectomies,frenectomies, benignand malignant lesionremoval, biopsies,leukoplakia andfibrotomy.Podiatry:Warts, plantar verrucae,large mosaic verrucaeand matrixectomy.Pulmonary Surgery:Open and endoscopicpulmonary surgery.Thoracic Surgery:Surgicalincision/excision | Indications includesoft tissuesurrounding the eyeand orbit andanteriorcapsulotomy.Oral/MaxillofacialIndications includeoral/dentalprocedures forincision, excision,ablation,vaporization andhemostasis of softtissue duringgingivoplasties,gingivectomies,frenectomies,benign andmalignant lesionremoval, biopsies,leukoplakia andfibrotomy.ENT SurgeryENT surgery in soft,mucosal,cartilaginous andbony tissue | ||||
| DescriptiveInformation | Waterlase iPlus S | Oculase MD(K052354) | Waterlase MDDerm(K071734) | Profile Multi-Platform System(K060033) | Laserscope VELA(K971843) |
| vaporization and | including: endosinus | ||||
| coagulation of soft | surgery, functional | ||||
| tissue during any | endoscopic sinus | ||||
| thoracic surgery. | surgery, turbinate | ||||
| procedures (e.g. | |||||
| turbinoplasty, | |||||
| turbinectomy), | |||||
| dacryocysto- | |||||
| rhinostomy (DCR), | |||||
| ethmoidectomy, | |||||
| polypectomy, | |||||
| maxillary | |||||
| antrotomy, frontal | |||||
| sinusotomy, | |||||
| sphenoidotomy, | |||||
| hereditary | |||||
| hemorrhagic | |||||
| telangiectasia, | |||||
| septoplasty. | |||||
| Podiatry | |||||
| Indications include | |||||
| warts, plantar | |||||
| verrucae, large | |||||
| mosaic verrucae and | |||||
| matrixectomy. | |||||
| Pulmonary Surgery | |||||
| Open and | |||||
| endoscopic | |||||
| pulmonary surgery. | |||||
| DescriptiveInformation | Waterlase iPlus S | Oculase MD(K052354) | Waterlase MDDerm(K071734) | Profile Multi-Platform System(K060033) | Laserscope VELA(K971843) |
| Thoracic SurgeryIntended for thesurgicalincision/excision,vaporization andcoagulation of softtissue during anythoracic surgery. | |||||
| LaserClassification | IV (4) | IV (4) | IV (4) | IV (4) | IV (4) |
| OperatingVoltage | 100 VAC ± 10%230VAC ± 10% | 100 VAC ± 10%230VAC ± 10% | 100 VAC ± 10%230VAC ± 10% | 200 - 240 VAC | 220 VAC |
| Laser Medium | ER,CR:YSGG | ER,CR:YSGG | ER,CR:YSGG | ER:YAG | ER:YAG |
| Wavelength | 2.78μm (2780nm) | 2.78μm (2780nm) | 2.78μm (2780nm) | 2940nm | 2940nm |
| CurrentFrequency | 50 - 60 Hz | 50 - 60 Hz | 50 - 60 Hz | 50 - 60 Hz | Not available |
| Max OutputPower | 10 watts ± 20% | 8 watts ± 20% | 8 watts ± 20% | 45 watts ± 20% | 45 watts |
| Power Mode | Pulsed Free Running | Pulsed Free Running | Pulsed FreeRunning | Not available | Not available |
| Cooling | Water | Water | Water | Not available | Not available |
| Pulse Duration | 60µs, 700µs | 60µs, 700µs | 60µs, 700µs | 100 µs - 5ms | Not available |
| Aiming Beam | Laser Diode, max 1mW,635nmClass I | Laser Diode, max1mW, 635nmClass I | Laser Diode, max1mW, 635nmClass I | Laser Diode, max5mW, 650nm ± 5nmClass II | Not available |
| DescriptiveInformation | Waterlase iPlus S | Oculase MD(K052354) | Waterlase MDDerm(K071734) | Profile Multi-Platform System(K060033) | Laserscope VELA(K971843) |
| Materials | Medical grade plastics,steel, stainless steel,aluminum, brass, andelectronic parts andcomponents | Medical gradeplastics, steel,stainless steel,aluminum, brass,and electronic partsand components | Medical gradeplastics, steel,stainless steel,aluminum, brass,and electronicparts andcomponents | Medical gradeplastics, steel,stainless steel,aluminum, brass,and electronic partsand components | Medical gradeplastics, steel,stainless steel,aluminum, brass,and electronicparts andcomponents |
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Non-Clinical Test Data
Safety testing of the Waterlase iPlus S was successfully completed according to IEC 60601-1 - Medical electrical equipment, Part 1: General requirements for safety and essential performance, IEC 60601-1-2 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance -collateral standard: electromagnetic compatibility- requirements and tests, IEC 60825-1 Safety of laser products - Part 1: Equipment classification and requirements, IEC 60601-2-22 Medical electrical equipment- Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
Software verification and validation was conducted due to modifications of layout of the Graphical User Interface resulting from the expanded indications for use. The results demonstrate that the Waterlase iPlus S performs according to specifications and functions intended.
No other performance testing was conducted since the purpose of this 510(k) is to only expand the Indications for Use from the previous 510(k) clearances under 510(k) Nos.: K101658 and K122368. All indications included in this 510(k) have already been cleared by the FDA for equivalent medical devices manufactured by Biolase, Inc., Sciton, Inc. and Laserscope.
Clinical Test Data
Clinical testing was not conducted on this device.
Conclusion
Based upon the comparison of the Waterlase iPlus S with the same device, Waterlase iPlus, Profile Multi-Platform System and Laserscope VELA previously cleared by the FDA, the clinical performance of the Waterlase iPlus S for the Indications for Use described above is deemed to be substantially equivalent to the legally-marketed predicate devices, the Waterlase iPlus, Profile Multi-Platform System and Laserscope VELA.
§ 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.