(451 days)
No
The summary describes a laser device with a microprocessor and touch screen interface, but there is no mention of AI or ML in the intended use, device description, or performance studies. The software verification and validation are described as conforming to IEC 62304, which is a standard for medical device software lifecycle processes, not specifically for AI/ML.
Yes
The device is indicated for various medical and dental treatments, including skin resurfacing, caries removal, root canal treatments, bone surgeries, and soft tissue procedures, all of which aim to treat conditions or restore functions, thus qualifying it as a therapeutic device.
No
Explanation: The device is a laser used for surgical and cosmetic procedures like skin resurfacing, cavity preparation, tissue removal, and bone cutting. It performs therapeutic and ablative actions, not diagnostic ones.
No
The device description clearly outlines hardware components including a console housing the laser head, power supply, cooling system, microprocessor, electronics, a footswitch, a fiber optic cable, and a handpiece. While it has a software user interface, it is fundamentally a hardware device that utilizes software for control.
Based on the provided information, the Waterlase iPlus is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used for direct treatment of patients through procedures like skin resurfacing, cavity preparation, tissue removal, and various surgical interventions.
- Device Description: The description details a laser system that delivers energy and water directly to the treatment site on the patient.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening. The note about submitting tissue growth for histopathological evaluation is a separate diagnostic step performed by a laboratory, not the function of the Waterlase iPlus itself.
IVD devices are specifically designed to perform tests on samples taken from the human body. The Waterlase iPlus is a therapeutic device used for surgical and ablative procedures directly on the patient.
N/A
Intended Use / Indications for Use
Waterlase iPlus with the fractional handpiece is indicated for use in dermatology for skin resurfacing.
Waterlase iPlus when used with the non-fractional handpieces is indicated for use in the following oral hard and soft tissue dental applications:
Waterlase laser removal of porcelain and ceramic crowns and veneers
General Hard Tissue Indications (for use on adult and pediatric patients)
- · Class I, II, III, IV and V cavity preparation
- · Caries removal
- Hard tissue surface roughening or etching
- · Enameloplasty, excavation of pits and fissures for placement of sealants
Root Canal Hard Tissue Indications
- · Tooth preparation to obtain access to root canal
- · Root canal preparation including enlargement
- 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
· 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 (for use on adult and pediatric patient) Incision, excision, vaporization, ablation and coagulation of oral soft tissues including:
- · Excisional and incisional biopsies
- Exposure of unerupted teeth
- Fibroma removal
- · Flap preparation incision of soft tissue to prepare a flap and expose the bone
- · Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
- · Frenectomy and frenotomy
- · Gingival troughing for crown impressions
- · Gingivectomy
- Gingivoplasty
- Gingival incision and excision
- Hemostasis
- · Implant recovery
- Incision and drainage of abscesses
- · Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
- Leukoplakia
- Operculectomy
- Oral papillectomies
- Pulpotomy
- Pulp extirpation
- · Pulpotomy as an adjunct to root canal therapy
- Root canal debridement and cleaning
- Reduction of gingival hypertrophy
- · Soft tissue crown lengthening
- · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- · Vestibuloplasty
· 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.
Laser Periodontal Procedures
- Full thickness flap
- Partial thickness flap
- · Split thickness flap
- · Laser soft tissue curettage
- · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium
- · 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 physiologic osseous contours)
- · Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
- · Osseous crown lengthening
- · Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
• Waterlase Er.Cr: Y SGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONG
Device Description
Waterlase iPlus utilizes an Er, Cr YSGG (2780nm) solid-state laser and water atomization technology for hard and soft tissue incision, excision, ablation, vaporization and coagulation of soft and hard tissue.
The laser consists of a console the houses the laser head, power supply, cooling system, micro-processor and electronics, a footswitch which activates the laser, and a fiber optic cable for delivery of laser energy through a handpiece to the treatment site. A fine water spray is also emitted from the handpiece to cool and hydrate the issue. The laser is controlled through a touch screen display which serves as the User Interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, oral hard and soft tissue, root canal, bone, pulpal tissues, periodontal pocket
Indicated Patient Age Range
Adult and pediatric patients for oral hard and soft tissue dental applications.
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)
The following non-clinical and clinical performance information was provided in support of substantial equivalence determination:
Biocompatibility Testing
The biocompatibility evaluation for Waterlase iPlus Laser System was conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process, as recognized by the FDA. The addition of the Fraction Handpiece accessory cytotoxicity testing was completed on the only patient contacting disposable accessory applicator.
Software Verification and Validation
Software verification and validation were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices The results demonstrate that the Waterlase iPlus Laser System performs according to specifications and functions intended. The software design conforms with the IEC 62304 standard -Medical device software- software life cycle processes.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted for the Waterlase iPlus Laser System. The device complies with the current revisions of the recognized standards IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 80601-2-60 for safety and IEC 60601-1-2 for EMC.
Performance Testing- Bench
In an effort to ensure adding this accessory handpiece to the iPlus Laser System as well as the dermatological indication was as safe and effective as the predicate devices performance bench testing was completed. A verification of the Fractional Handpiece and trunk fiber designs was completed to gather data for peak performance settings. Verification of accessory requirements was also completed, and the accessory passed all requirement criteria.
Performance Testing - Animal
Ex-vivo and in-vivo animal tissue testing was conducted to assess the depth and width of penetration produced with the fractional handpiece. The results support that the device can be used to produce fractional beam micro-ablation depths and widths that are within the range of other fractional laser devices cleared for dermatological skin resurfacing.
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 21, 2022
Biolase, Inc. Ed Balcos Senior Regulatory Affairs Specialist 27042 Towne Centre Drive, Suite 270 FootHill Ranch, California 92610
Re: K210183
Trade/Device Name: Waterlase iPLus 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, ONG Dated: January 22, 2021 Received: January 25, 2021
Dear Ed Balcos:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya, D.Eng. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210183
Device Name Waterlase iPlus Laser System
Indications for Use (Describe)
Waterlase iPlus with the fractional handpiece is indicated for use in dermatology for skin resurfacing.
Waterlase iPlus when used with the non-fractional handpieces is indicated for use in the following oral hard and soft tissue dental applications:
Waterlase laser removal of porcelain and ceramic crowns and veneers
General Hard Tissue Indications (for use on adult and pediatric patients)
- · Class I, II, III, IV and V cavity preparation
- · Caries removal
- Hard tissue surface roughening or etching
- · Enameloplasty, excavation of pits and fissures for placement of sealants
Root Canal Hard Tissue Indications
- · Tooth preparation to obtain access to root canal
- · Root canal preparation including enlargement
- 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
· 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 (for use on adult and pediatric patient) Incision, excision, vaporization, ablation and coagulation of oral soft tissues including:
- · Excisional and incisional biopsies
- Exposure of unerupted teeth
- Fibroma removal
- · Flap preparation incision of soft tissue to prepare a flap and expose the bone
- · Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
3
- · Frenectomy and frenotomy
- · Gingival troughing for crown impressions
- · Gingivectomy
- Gingivoplasty
- Gingival incision and excision
- Hemostasis
- · Implant recovery
- Incision and drainage of abscesses
- · Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
- Leukoplakia
- Operculectomy
- Oral papillectomies
- Pulpotomy
- Pulp extirpation
- · Pulpotomy as an adjunct to root canal therapy
- Root canal debridement and cleaning
- Reduction of gingival hypertrophy
- · Soft tissue crown lengthening
- · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- · Vestibuloplasty
· 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.
Laser Periodontal Procedures
- Full thickness flap
- Partial thickness flap
- · Split thickness flap
- · Laser soft tissue curettage
- · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium
- · 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 physiologic osseous contours)
- · Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
- · Osseous crown lengthening
- · Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
• Waterlase Er.Cr: Y SGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
OLASF
510(k) SUMMARY
I. SUBMITTER
Biolase,Inc. 27042 Towne Centre Drive Suite 270 Foothill Ranch, CA 92610 Tel: (949) 226-8119 Fax: (949) 273-6688 Contact Person: Ed Balcos Tel: (949) 361-1200 ebalcos@biolase.com Date: March 21, 2022
II. DEVICE
| Name of Device: | Waterlase iPlus Laser System, Fractional Handpiece |
|---|---|
| Common Name: | Er, Cr YSGG Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810) |
| Device Class: | II |
| Product Code: | GEX, ONG |
III. PREDICATE DEVICES
Pearl Fractional Handpiece, Cutera, Inc., K080530 FS-01 Handpiece, Fotona, d.d., K132806 REFERENCE DEVICE Waterlase iPlus S, Biolase, Inc., K141975
IV. DEVICE DESCRIPTION
Waterlase iPlus utilizes an Er, Cr YSGG (2780nm) solid-state laser and water atomization technology for hard and soft tissue incision, excision, ablation, vaporization and coagulation of soft and hard tissue.
The laser consists of a console the houses the laser head, power supply, cooling system, micro-processor and electronics, a footswitch which activates the laser, and a fiber optic cable for delivery of laser energy through a handpiece to the treatment site. A fine water spray is also emitted from the handpiece to cool and hydrate the issue. The laser is controlled through a touch screen display which serves as the User Interface.
6
BOLASE
V. INDICATIONS FOR USE
Waterlase iPlus with the fractional handpiece is indicated for use in dermatology for skin resurfacing.
Waterlase iPlus when used with non-fractional handpieces is indicated for use in the following oral hard and soft tissue dental applications:
Waterlase laser removal of porcelain and ceramic crowns and veneers
General Hard Tissue Indications (for use on adult and pediatric patients)
- Class I, II, III, IV and V cavity preparation ●
- Caries removal o
- Hard tissue surface roughening or etching o
- Enameloplasty, excavation of pits and fissures for placement of sealants ●
Root Canal Hard Tissue Indications
- Tooth preparation to obtain access to root canal
- Root canal preparation including enlargement ●
- Root canal debridement and cleaning ●
Root Canal Disinfection
- Laser root canal disinfection after endodontic treatment 0
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 o
- 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.
Bone Surgical Indications
- Cutting, shaving, contouring and resection of oral osseous tissues (bone) ●
- Osteotomy ●
Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patient)
- Incision, excision, vaporization, ablation and coagulation of oral soft tissues including:
- Excisional and incisional biopsies ●
- Exposure of unerupted teeth
- Fibroma removal
- Flap preparation incision of soft tissue to prepare a flap and expose the bone ●
7
K210183
BIOLASE
- Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth ● (hard and soft tissue impactions)
- Frenectomy and frenotomy
- Gingival troughing for crown impressions
- Gingivectomy ●
- Gingivoplasty
- Gingival incision and excision
- Hemostasis
- Implant recovery ●
- Incision and drainage of abscesses
- Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
- Leukoplakia
- Operculectomy ●
- Oral papillectomies
- Pulpotomy
- Pulp extirpation ●
- Pulpotomy as an adjunct to root canal therapy
- Root canal debridement and cleaning ●
- Reduction of gingival hypertrophy
- Soft tissue crown lengthening ●
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa ●
- Vestibuloplastv ●
- 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.
Laser Periodontal Procedures
- Full thickness flap ●
- Partial thickness flap
- Split thickness flap
- Laser soft tissue curettage ●
- Laser removal of diseased, inflamed and necrosed soft tissue within the ● periodontal pocket
- o Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium
- 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 index, 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 ●
8
Image /page/8/Picture/2 description: The image shows the word "BIOLASE" in large, bold, blue letters. The letters are closely spaced together, filling most of the frame. The background is white.
grafting, etc.)
- Osseous crown lengthening
- o Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
- . Waterlase Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| | Subject Device | Predicate
(primary) | Predicate
(secondary) | Reference
Device |
|-------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------|----------------------------------------|---------------------|
| Specification | Biolase Fractional
Handpiece | Cutera Pearl
Fractional
Handpiece | Fotona FS01
Fractional
Handpiece | Biolase iPlus S |
| 510(k) Number | K210183 | K080530 | K132806 | K141975 |
| Laser medium | Er,Cr YSGG | Er YSGG | Er YAG | Er,Cr YSGG |
| Wavelength | 2780 nm | 2790 nm | 2940 nm | 2780 nm |
| Operating modes | pulsed | pulsed | pulsed | pulsed |
| Pulse width, us | 60 µs, 700 µs |