(227 days)
No
The summary describes a laser surgical instrument and its various applications. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description or performance studies. The software modifications mentioned relate to the Graphical User Interface layout, not AI/ML functionality.
Yes.
The device is intended for use as a laser surgical instrument for incision, excision, vaporization, ablation, and coagulation of various soft tissues, which are all therapeutic actions.
No.
The device is described as a laser surgical instrument intended for incision, excision, vaporization, ablation, and coagulation of soft tissue across various medical specialties. While it can be used for diagnostic biopsies, its primary function is therapeutic surgical intervention, not diagnosis.
No
The device description explicitly states it is a solid state laser system consisting of a cabinet housing hardware components like a power supply, cooling system, laser, foot switch, and fiber optic. It also mentions various handpieces and tip types. This is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a "laser surgical instrument" for various surgical procedures involving the incision, excision, vaporization, ablation, and coagulation of soft tissue. This is a therapeutic and surgical function, not a diagnostic one.
- Device Description: The device description details a laser system that delivers optical energy for surgical purposes. It does not mention any components or functions related to analyzing biological samples (like blood, urine, or tissue) outside of the body, which is the core function of an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples in vitro (outside the living body).
- Detecting or measuring specific substances or markers in samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The Waterlase iPlus S is a surgical device used directly on the patient's tissues for treatment purposes.
N/A
Intended Use / Indications for 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 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 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dermatology/Plastic Surgery: dermatologic tissues
Ear, Nose and Throat (ENT): soft, mucosal, cartilaginous and bony tissue
Gastroenterology: soft tissue, sigmoid colon, gall bladder, biliary/bile duct, esophagus, stomach, colon, pancreas
General Surgery: soft tissue, skin, internal organs
Genitourinary/Urology: soft tissue, bladder, urethra, ureters, penis, scrotum, external genitalia, anus, prostate
Gynecology: cervix, endometrium
Ophthalmology: ocular tissue, tissue surrounding the eye and orbit
Oral/Maxillofacial Surgery: soft tissue
Podiatry: Not Specified
Pulmonary Surgery: lung/pulmonary
Thoracic Surgery: thoracic soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Data: Safety testing was successfully completed according to IEC 60601-1, IEC 60601-1-2, IEC 60825-1, and IEC 60601-2-22. Software verification and validation was conducted due to GUI modifications for expanded indications. The results demonstrate that the Waterlase iPlus S performs according to specifications and functions intended. No other performance testing was conducted as the 510(k) purpose was to expand Indications for Use already cleared for equivalent medical devices.
Clinical Test Data: Clinical testing was not conducted on this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K052354, K071734, K060033, K971843
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
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
2
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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4
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.
7
| Descriptive
Information | Waterlase iPlus S | Oculase MD
(K052354) | Waterlase MD
Derm
(K071734) | Profile Multi-
Platform System
(K060033) | Laserscope VELA
(K971843) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Biolase, Inc. | Biolase, Inc. | Biolase, Inc. | Sciton, Inc. | Laserscope |
| Indications for
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 Oculase MD
may be indicated for
general ophthalmic
soft tissue surgical
indications such as:
Incision, excision,
vaporization and
coagulation of
ocular tissue and
tissue surrounding
the eye and orbit. | Use of the device
is indicated for
the incision,
excision, ablation,
vaporization and
coagulation of
dermatologic
tissues including
epidermal nevi,
cheilitis, keloids,
verrucae, skin
tags, keratosis,
scar revision,
debulking of
tumors, cysts,
diagnostic biopsy
and skin
resurfacing.
Use of the device
is further
indicated for the
incision, excision,
vaporization and
coagulation of
soft tissue during
general surgical
applications | 2940nm Indications
for Use:
The Profile Multi-
Platform and
Accessories are
designed 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,
cartilage meniscus,
calculi or fragments,
mucous membrane,
lymph vessels and
nodes, organs and
glands. Surgical
specialties and
applications include
general surgery. | The Laserscope
VELA Erbium:YAG
Laser System and
Accessories are
intended for the
surgical
incision/excision,
vaporization and
coagulation of soft
tissue. All soft
tissue is included,
such as skin,
subcutaneous
tissue, striated
and smooth
tissue, muscle,
cartilage
meniscus, mucous
membrane, lymph
vessels and nodes,
organs and glands.
Dermatology/
Plastic Surgery:
Indications
include, epidermal
nevi,
telangiectasia,
spider veins. |
| Descriptive
Information | Waterlase iPlus S | Oculase MD
(K052354) | Waterlase MD
Derm
(K071734) | Profile Multi-
Platform System
(K060033) | Laserscope VELA
(K971843) |
| | 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. | | 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. | plastic surgery,
aesthetic surgery,
dermatology,
urology, gynecology,
genitourinary, ENT,
pulmonary, surgery,
thoracic surgery,
podiatry, oral &
maxillofacial
surgery,
ophthalmology
(including
oculoplasty), small
and large joint
arthroscopy, micro-
discectomies and
endoscopic
procedures. | actinic cheilitis,
keloids, verrucae,
skin tags, anal
tags, keratoses,
scar revision,
debulking benign
tumors, decubitis
ulcers and skin
resurfacing.
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 and
lesions tissue |
| | Ear, Nose and Throat
(ENT):
ENT surgery in soft,
mucosal, cartilaginous
and bony tissue,
including endosinus
surgery, functional
endoscopic sinus
surgery, turbinate
procedures (e.g.
turbinoplasty,
turbinectomy) | | | Aesthetic Surgery
Skin resurfacing and
treatment of
wrinkles.
Dermatology &
Plastic Surgery
Indications include,
epidermal nevi,
telangiectasia,
spider veins, actinic
cheilitis, keloids | |
| Descriptive
Information | Waterlase iPlus S | Oculase MD
(K052354) | Waterlase MD
Derm
(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 | |
| Descriptive
Information | Waterlase iPlus S | Oculase MD
(K052354) | Waterlase MD
Derm
(K071734) | Profile Multi-
Platform System
(K060033) | Laserscope VELA
(K971843) |
| | colitis, ulcers, | | | angiodysplasia, | adhesions, cysts |
| | angiodysplasia, | | | hemorrhoids, | and condyloma. |
| | hemorrhoids, varices, | | | varices, esophagitis, | ENT
Indications |
| | 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 | |
| Descriptive
Information | Waterlase iPlus S | Oculase MD
(K052354) | Waterlase MD
Derm
(K071734) | Profile Multi-
Platform System
(K060033) | Laserscope VELA
(K971843) |
| | resection of internal
organs, tumors and
lesions, tissue ablation
and/or vessel
coagulation may be
indicated. | | | skin incision, tissue
dissection, excision
of external tumors
and lesions,
complete or partial
resection of internal
organs, tumors,
tissue ablation
and/or vessel
coagulation. | large mosaic
verrucae and
matrixectomy. |
| | Genitourinary/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,
urethra and anus, penis,
scrotum, (includes
condyloma acuminate,
giant perineal
condyloma and
verrucous carcinoma),
vulvar lesions, polyps
and familial polyps of | | | Genitourinary/
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; | |
| Descriptive
Information | Waterlase iPlus S | Oculase MD
(K052354) | Waterlase MD
Derm
(K071734) | Profile Multi-
Platform System
(K060033) | Laserscope VELA
(K971843) |
| | the colon, 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.
Gynecology:
Cervical intraepithelial
neoplasia (CIN), herpes
simplex, endometrial
adhesions, cysts and
condyloma.
Ophthalmology:
General ophthalmic soft
tissue surgical
indications such as:
Incision, excision,
vaporization and
coagulation of ocular
tissue and tissue | | | 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.
Gynecology
Indications include
cervical
intraepithelial
neoplasia (CIN),
herpes simplex,
endometrial
adhesions, cysts and
condyloma.
Ophthalmology | |
| Descriptive
Information | Waterlase iPlus S | Oculase MD
(K052354) | Waterlase MD
Derm
(K071734) | Profile Multi-
Platform System
(K060033) | Laserscope VELA
(K971843) |
| surrounding the eye and
orbit.
Oral/Maxillofacial
Surgery:
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:
Warts, plantar verrucae,
large mosaic verrucae
and matrixectomy.
Pulmonary Surgery:
Open and endoscopic
pulmonary surgery.
Thoracic Surgery:
Surgical
incision/excision | | | | Indications include
soft tissue
surrounding the eye
and orbit and
anterior
capsulotomy.
Oral/
Maxillofacial
Indications include
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.
ENT Surgery
ENT surgery in soft,
mucosal,
cartilaginous and
bony tissue | |
| Descriptive
Information | Waterlase iPlus S | Oculase MD
(K052354) | Waterlase MD
Derm
(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. | |
| Descriptive
Information | Waterlase iPlus S | Oculase MD
(K052354) | Waterlase MD
Derm
(K071734) | Profile Multi-
Platform System
(K060033) | Laserscope VELA
(K971843) |
| | | | | Thoracic Surgery
Intended for the
surgical
incision/excision,
vaporization and
coagulation of soft
tissue during any
thoracic surgery. | |
| Laser
Classification | IV (4) | IV (4) | IV (4) | IV (4) | IV (4) |
| Operating
Voltage | 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 |
| Current
Frequency | 50 - 60 Hz | 50 - 60 Hz | 50 - 60 Hz | 50 - 60 Hz | Not available |
| Max Output
Power | 10 watts ± 20% | 8 watts ± 20% | 8 watts ± 20% | 45 watts ± 20% | 45 watts |
| Power Mode | Pulsed Free Running | Pulsed Free Running | Pulsed Free
Running | 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,
635nm
Class I | Laser Diode, max
1mW, 635nm
Class I | Laser Diode, max
1mW, 635nm
Class I | Laser Diode, max
5mW, 650nm ± 5nm
Class II | Not available |
| Descriptive
Information | Waterlase iPlus S | Oculase MD
(K052354) | Waterlase MD
Derm
(K071734) | Profile Multi-
Platform System
(K060033) | Laserscope VELA
(K971843) |
| Materials | Medical grade plastics,
steel, stainless steel,
aluminum, brass, and
electronic parts and
components | Medical grade
plastics, steel,
stainless steel,
aluminum, brass,
and electronic parts
and components | Medical grade
plastics, steel,
stainless steel,
aluminum, brass,
and electronic
parts and
components | Medical grade
plastics, steel,
stainless steel,
aluminum, brass,
and electronic parts
and components | Medical grade
plastics, steel,
stainless steel,
aluminum, brass,
and electronic
parts and
components |
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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.