WATERLASE IPLUS ALL TISSUE LASER
Device Facts
| Record ID | K122368 |
|---|---|
| Device Name | WATERLASE IPLUS ALL TISSUE LASER |
| Applicant | Biolase Technology, Inc. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | May 2, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The Orthopedic iPlus Soft Tissue Loser is intended for use as a laser surgical instrument in orthopedic and podiatric surgery. It is indicated for the following Indications for Use, including the previously cleared dental indications, for completeness: [Dental, Endodontic, Bone, Soft Tissue, and Periodontal indications listed in document]. ORTHOPEDIC INDICATIONS FOR USE: Incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an arthroscope, in contact and non-contact with tissue, in orthopedic and podiatric surgery, including: Soft and cartilaginous tissue in small and large joints (e.g., knee meniscectomy, debridement of inflamed synovial tissue).
Device Story
The Orthopedic iPlus Soft Tissue Laser is an Er, Cr:YSGG solid-state laser (2.78 μm wavelength) used for surgical soft tissue and bone procedures. The system comprises a cabinet housing a power supply, cooling system, microcontroller, laser source, and foot switch, with a fiber-optic handpiece for energy delivery. It operates with or without atomized water droplets for tissue cooling and hydration. Used in clinical settings by surgeons, the device enables precise incision, resection, ablation, vaporization, coagulation, and hemostasis. It can be used with or without an arthroscope for joint procedures. The physician controls the laser via a foot switch; the output provides thermal energy to target tissues. Clinical benefits include controlled tissue removal and hemostasis, potentially reducing trauma compared to traditional mechanical instruments.
Clinical Evidence
Bench testing only. No clinical data provided. Substantial equivalence is based on technological characteristics and performance specifications compared to legally marketed predicate devices.
Technological Characteristics
Er, Cr:YSGG solid-state laser; 2.78 μm wavelength. System includes cabinet, power supply, cooling system, microcontroller, and fiber-optic handpiece. Operates with/without atomized water. Class II device. Regulated under 21 CFR 878.4810.
Indications for Use
Indicated for adult and pediatric patients requiring laser surgical procedures in dental, endodontic, periodontal, orthopedic, and podiatric applications. Includes soft tissue incision, excision, ablation, vaporization, coagulation, hemostasis, and bone surgery. Contraindications: Any tissue growth (cysts, neoplasms, lesions) must be submitted for histopathological evaluation.
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
- Sciton's Profile Multi-Platform System (K060033)
- CoolTouch Inc.'s CoolTouch Varia Nd:YAG Surgical Laser (K092964)
- Richard Wolf Medical Instruments Corporation's MegaPulse Laser System (K090776)
- Fotona's Fotona Dualis Laser System (K021548)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for BIOLASE Technology, Inc. The word "BIOLASE" is in large, bold, black letters on the left side of the image. To the right of the company name is the phrase "BIOLASE Technology, Inc." in a smaller font.
BIOLASE Technology, Inc.
K122368
510(k) Summary Orthopedic iPlus Soft Tissue Laser April 26, 2013
MAY - 2 2013
| Company: | Biolase Technology, Inc.<br>4 Cromwell<br>Irvine, CA 92618 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration: | 2027755 |
| Company Contact: | Colleen Boswell<br>Vice President, Regulatory Affairs<br>Telephone: 949-226-8470<br>Fax: 949-273-6688 |
| Trade Name: | Orthopedic iPlus Soft Tissue Laser |
| Common Name: | Er, Cr: YSGG laser |
| Classification Name: | Powered laser surgical instrument |
| Classification: | Class II |
| Regulation Number: | Laser surgical instrument for use in general and plastic surgery and in<br>dermatology, per 21 CFR 878.4810 |
| Panel: | General and Plastic Surgery |
| Product Code: | GEX |
| Predicate Devices: | Sciton's Profile Multi-Platform System (K060033)<br>CoolTouch Inc.'s CoolTouch Varia Nd:YAG Surgical Laser (K092964)<br>Richard Wolf Medical Instruments Corporation's MegaPulse Laser System (K090776)<br>Fotona's Fotona Dualis Laser System (K021548) |
## Device Description:
The Orthopedic iPlus Soft Tissue Laser is an erbium, yttrium, scandium, gallium 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, microcontroller, laser, foot switch, and fiber optic for delivery of laser energy with fiber optic handpiece setup. The Orthopedic iPlus Soft Tissue Loser utilizes direct laser energy either with or
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without water for cooling and hydration to perform soft tissue incision, resection, ablation, vaporization, coagulation and hemostasis.
# Indications for Use:
The Orthopedic iPlus Soft Tissue Loser is intended for use as a laser surgical instrument in orthopedic and podiatric surgery. It is indicated for the following Indications for Use, including the previously cleared dental indications, for completeness:
# DENTAL INDICATIONS FOR USE
# General Indications*
- Class I, II, III, IV and V cavity preparation 트
- I Caries removal
- . Hard tissue surface roughening or etching
- 트 Enameloplasty, excavation of pits and fissures for placement of sealants
*For use on adult and pediatric patients
# Root Canal Hard Tissue Indications
- Tooth preparation to obtain access to root canal
- l Root canal preparation including enlargement
- 트 Root canal debridement and cleaning
# Root Canal Disinfection
- Laser root canal disinfection after endodontic treatment
# Endodontic Surgery (Root Amputation) Indications
- Flap preparation incision of soft tissue to prepare a flap and expose the bone .
- . Cutting bone to prepare a window access to the apex (apices) of the root(s)
- Apicoectomy amputation of the root end ■
- Root end preparation for retrofill amalgam or composite
- l Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
# Bone Surgical Indications
- Cutting, shaving, contouring and resection of oral osseous tissues (bone) .
- . Osteotomy
# Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
- I Excisional and incisional biopsies
- . Exposure of unerupted teeth
- l Fibroma removal
- 1 Flap preparation - incision of soft tissue to prepare a flap and expose the bone
- l Flap preparation - incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
- 미 Frenectomy and frenotomy
- 동 Gingival troughing for crown impressions
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- 1 Gingivectomy
- 트 Gingivoplasty
- . Gingival incision and excision
- . Hemostasis
- 트 Implant recovery
- 트 Incision and drainage of abscesses
- l Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
- Leukoplakia
- Operculectomy
- l Oral papillectomies
- 트 Pulpotomy
- 미 Pulp extirpation
- 비 Pulpotomy as an adjunct to root canal therapy
- 트 Root canal debridement and cleaning
- 트 Reduction of gingival hypertrophy
- . Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
- . Soft tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa i
- 1 Vestibuloplasty
- *For use on adult and pediatric patient
# Laser Periodontal Procedures
- I Full thickness flap
- 트 Partial thickness flap
- . Split thickness flap
- 해 Laser soft tissue curettage
- Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal I pocket
- Removal of highly inflamed edematous tissue affected by bacterial perpetration of the pocket lining 대 junctional epithelium
- 미 Removal of granulation tissue from bony defects
- Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the ■ periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility)
- Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create 미 physiologic osseous contours)
- Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.) .
- Osseous crown lengthening
- l Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
- Waterlase MD Er,Cr:YSSG assisted new attachment procedure (cementum-mediated ■ periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)
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# ORTHOPEDIC INDICATIONS FOR USE
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an arthroscope, in contact and non-contact with tissue, in orthopedic and podiatric surgery, including:
- . Soft and cartilaginous tissue in small and large joints (e.g., knee meniscectomy, debridement of inflamed synovial tissue)
## Substantial Equivalence:
The subject device proposed indications for orthopedic and podiatric surgery are substantially equivalent to the indications of Sciton's Profile Multi-Platform System (K060033), CoolTouch Inc.'s CoolTouch Varia Nd:YAG Surgical Laser (K092964), Richard Wolf Medical Instruments Corporation's MegaPulse Laser System (K090776) and Fotona's Fotona Dualis Laser System (K021548). Additionally, the Orthopedic iPlus Soft Tissue Laser is substantially equivalent in materials, dimensions, weight, operating voltage, current frequency, laser medium, wavelength, max power mode, pulse energy, pulse duration, cooling and aiming beam to specifications of Sciton's Profile Multi- Platform System (K060033), CoolTouch Inc.'s CoolTouch Varia Nd:YAG Surgical Laser (K092964), Richard Wolf Medical Instruments Corporation's MegaPulse Laser System (K090776) and Fotona's Fotona Dualis Laser System (K021548).
## Conclusion:
Comparison of this device with the previously cleared devices provided in this 510(k) submission demonstrates the safety and effectiveness of this device for the above indications, and supports substantial equivalence to the legally-marketed predicate devices.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three curved lines or strokes, possibly representing human figures or abstract shapes.
# DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Biolase Technology, Inc. % Ms. Colleen Boswell Vice President, Regulatory Affairs 4 Cromwell Irvine, California 92618
May 2, 2013
Re: K122368
Trade/Device Name: Orthopedic iPlus Soft Tissue Laser 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: March 18, 2013 Received: March 19, 2013
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
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Page 2 – Ms. Colleen Boswell
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 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 go to http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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, FOR
PeteriDERumm-S
Mark N. Melkerson Acting 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): K122368
## Device Name: Orthopedic iPlus Soft Tissue Laser
#### Indications for Use:
The Orthopedic iPlus Soft Tissue Loser is intended for use as a laser surgical instrument in orthopedic and podiatric surgery. It is indicated for the following Indications for Use, including the previously cleared dental indications, for completeness:
#### DENTAL INDICATIONS FOR USE
#### General Indications*
- Class 1, 11, III, IV and V cavity preparation I
- 트 Caries removal
- . Hard tissue surface roughening or etching
- . Enameloplasty, excavation of pits and fissures for placement of sealants
*For use on adult and pediatric patients
## Root Canal Hard Tissue Indications
- Tooth preparation to obtain access to root canal 트
- 트 Root canal preparation including enlargement
- 트 Root canal debridement and cleaning
#### Root Canal Disinfection
- Laser root canal disinfection after endodontic treatment r
#### Endodontic Surgery (Root Amoutation) Indications
- . Flap preparation - incision of soft tissue to prepare a flap and expose the bone
- Cutting bone to prepare a window access to the apex (apices) of the root(s)
- . Apicoectomy - amputation of the root end
- D Root end preparation for retrofill amalgam or composite
- . Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
| Prescription Use X | AND/OR | Over-The-Counter Use |
|-----------------------------|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) |
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
| Neil R Ogdens | |
| 2013.05.01 14:13:48 -04'00' | |
| (Division Sign-Off) for MXM | |
Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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#### Bone Surgical Indications
- . Cutting, shaving, contouring and resection of oral osseous tissues (bone)
- Osteotomy
# Soft Tissue Indications includina Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
- 미 Excisional and incisional biopsies
- 트 Exposure of unerupted teeth
- . Fibroma removal
- Flap preparation incision of soft tissue to prepare a flap and expose the bone l
- Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and 트 soft tissue impactions)
- 1 Frenectomy and frenotomy
- 마 Gingival troughing for crown impressions
- 트 Gingivectomy
- 1 Gingivoplasty
- 에 Gingival incision and excision
- 8 Hemostasis
- 이 Implant recovery
- 해 Incision and drainage of abscesses
- Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during 용 apical surgery
- l Leukoplakia
- . Operculectomy
- . Oral papillectomies
- . Pulpotomy
- 후 Pulp extirpation
- l Pulpotomy as an adjunct to root canal therapy
- l Root canal debridement and cleaning
- 마 Reduction of gingival hypertrophy
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues 트 (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/7/Picture/34 description: The image shows the name "Neil R Ogden" in bold font on the top line. The second line shows the date and time "2013.05.01 14:14:14 -04'00'". The date and time are also in bold font. The image is a close-up of the text.
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Page 2 of 3
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- 트 Soft tissue crown lengthening
- B Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- . Vestibuloplasty
*For use on adult and pediatric patient
## Laser Periodontal Procedures
- D Full thickness flap
- 1 Partial thickness flap
- B Split thickness flap
- Laser soft tissue curettage
- 트 Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- . Removal of highly inflamed edematous tissue affected by bacterial perpetration of the pocket lining junctional epithelium
- l Removal of granulation tissue from bony defects
- Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the 트 periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility)
- Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create . physiologic osseous contours)
- Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, 내 etc.}
- 1 Osseous crown lengthening
- Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open . curettage
- l Waterlase MD Er, Cr:YSSG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)
# ORTHOPEDIC INDICATIONS FOR USE
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an arthroscope, in contact and non-contact with tissue, in orthopedic and podiatric surgery, including:
- Soft and cartilaginous tissue in small and large joints (e.g., knee meniscectomy, debridement of . inflamed synovial tissue)
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R 0 2013.05.01 11: -04'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ K122368
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