Who is the manufacturer of GENTLERAY 980 DIODE LASER SYSTEM?

Kavo America filed the 510(k) submission for GENTLERAY 980 DIODE LASER SYSTEM (K072262).

What is the FDA product code for GENTLERAY 980 DIODE LASER SYSTEM?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for GENTLERAY 980 DIODE LASER SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for GENTLERAY 980 DIODE LASER SYSTEM?

Ceramoptec Ceralas D15 (K983058, K991891); ADT Diolase 980 D Laser System (K023547); Elexxion Claros (K063152).

Who can help prepare an FDA 510(k) submission like GENTLERAY 980 DIODE LASER SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GENTLERAY 980 DIODE LASER SYSTEM

K072262 · Kavo America · GEX · Oct 26, 2007 · General, Plastic Surgery

Device Facts

Record ID	K072262
Device Name	GENTLERAY 980 DIODE LASER SYSTEM
Applicant	Kavo America
Product Code	GEX · General, Plastic Surgery
Decision Date	Oct 26, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. The GENTLEray 980 Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.

Device Story

GENTLEray 980 is a portable diode laser system for intraoral soft tissue surgery. Device uses 980 nm wavelength laser energy delivered via contact fiber optic system to ablate, incise, excise, and coagulate tissue. System includes peristaltic pump for irrigation. Operated by dental professionals in clinical settings. Clinician controls laser parameters (power, pulse duration, frequency) via device interface; output is delivered to target tissue to achieve surgical goals like hemostasis or tissue removal. Benefits include precise tissue management and reduced bleeding during dental procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Validation included electrical safety, electromagnetic compatibility, and hardware/software functional testing to demonstrate performance equivalent to predicate devices.

Technological Characteristics

Diode laser system; 980 nm wavelength; 0.4-12W output power; pulsed or continuous operating modes; 635 nm red aiming beam; air-cooled; peristaltic pump for irrigation; steam autoclave sterilization for accessories; portable form factor (10.5" x 7" x 6"); 100-240V power requirement.

Indications for Use

Indicated for intra- and extra-oral soft tissue surgery including incision, excision, hemostasis, coagulation, and vaporization in adult and pediatric patients. Procedures include frenectomy, biopsy, gingivectomy, implant recovery, abscess drainage, and tooth whitening.

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

Ceramoptec Ceralas D15 (K983058, K991891)
ADT Diolase 980 D Laser System (K023547)
Elexxion Claros (K063152)

Related Devices

K023547 — DIOLASE 980 D LASER SYSTEM · American Dental Technologies, Inc. · Apr 15, 2003
K082445 — CURATIVE980 DIODE LASER · Oroscience, Inc. · Oct 15, 2008
K972325 — PULSEMASTER 1000 ST DENTAL LASER SYSTEM · American Dental Technologies, Inc. · Sep 19, 1997
K061366 — DENLASER 800 PLUS · CAO Group, Inc. · Jul 10, 2006
K042114 — MDL SERIES DIODE LASERS, MODEL MDL-10/15 · Vision Lasertechnik, GmbH · Feb 3, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ KO 72262 Image /page/0/Picture/1 description: The image contains two logos, one on the left and one on the right. The logo on the left is a stylized design, while the logo on the right contains the words "GENDEX" on the top line and "DEXIS" on the bottom line. The text in the logos is in a simple, sans-serif font. | Applicant: | KaVo Dental Corporation | OCT 26 2007 | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Address: | 340 East Main Street Lake Zurich, IL 60047 USA | | | Phone Number: Fax Number: | 847-550-6800 847-550-6825 | | | Contact Person: | Mari Lambert | | | Summary Prepared: | October 4, 2007 | | | Name of Device: | KaVO GENTLEray 980 | | | Trade Name: | GENTLEray 980 | | | Common Name: | GENTLEray | | | Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology | | | CFR Number: | 21 CFR §878.4810 | | | Product Code: | GEX | | | Product Description: | The GENTLEray 980 Diode Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. | | | Intended Use: | Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. The GENTLEray 980 Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of | | | Performance Standards: | The GENTLEray 980 Diode Dental Laser System complies with the appropriate sections of 21 CFR §1010 and 21 CFR §1040. | | | Substantial Equivalence: | The GENTLEray 980 Diode Dental Laser System has the same intended use and the same or substantially equivalent technical specifications and mechanism of action as compared with the named predicated devices. The KaVo GENTLEray 980 Diode Laser is substantially equivalent to the Ceramoptec Ceralas D15 (K983058, K991891) sold latterly under the BioLitec brand name SmilePro™ 980, the ADT Diolase 980 D Laser System (K023547) and the Elexxion Claros (K063152). Performance testing to validate the safety and effectiveness of the GENTLEray 980 Diode Dental Laser System includes electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions. The comparison of specifications are as follows: | | {1}------------------------------------------------ KO72262 | Specifications | Proposed Device | Predicate Device | Predicate Device | Predicate Device | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Wavelength | KaVo GENTLEray 980 | Biolitec Smilepro 980 | ADT Diolase 980 D | Elexxion Claros | | | 980 nm | 980 nm | 980 nm | 810 nm | | Output Power | 12W | 15W | 15 W | 30 W | | Power Range | .4 - 12W | 1-15W | .2 - 15 W | 0.01W - 30 W | | Increments | .2 - 1W | 1W | .2 - 1W | 0.01W - 1 W | | Operating Modes | Pulsed or Continuous | Pulsed or Continuous | Pulsed or Continuous | Pulsed or Continuous | | Pulse Duration ON | 25μs to 99.9 Sec. | 0.01 to 99.9 Sec. | 0.01 to 99.9 Sec | 25μs to 99.9 Sec. | | Pulse Duration OFF | 25μs to 99.9 Sec. | 0.01 to 99.9 Sec. | 0.01 to 99.9 Sec | 25μs to 99.9 Sec. | | Frequency | 20.000 Hz | 100 Hz | 100 Hz | 20.000 Hz | | Aiming beam | 635 nm, <1mW; Red | 635 nm, 4mW; Red | 635 nm, 4mW; Red | 635 nm, 4mW; Red | | Cooling | Air Cooled | Air Cooled | Air Cooled | Air Cooled | | Weight | 9 lbs. (4.5kg) | 15 lbs. (9kg) | 11 lbs. (5kg) | 48 lbs. (22kg) | | Dimensions | 10.5" x 7" x 6" | 14" x 9" x 7" | 14" x 9" x 3" | 33" x 18" x 20" | | Power Requirements | 100 - 240 V | 110/220 V | 110/220 V | 110/220 V | | Sterilization Methods | Steam Autoclave | Steam Autoclave | Steam Autoclave | Steam Autoclave | | Irrigant Supply | Peristaltic Pump | Peristaltic Pump | Peristaltic Pump | None | | Indications for Use | Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. The device is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of | Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. The device is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of | Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. The device is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of | Dental Soft Tissue Indications Including Pulpal Tissues* Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectomy | | | Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials. | Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials. | Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials. | incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscesses, Leukoplakia, Operculectomy, Oral papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, and Vestibuloplasty. *For use on adult and pediatric patients Laser Periodontal Procedures Laser soft tissue curettage, Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) Tooth Whitening Laser assisted whitening/bleaching of teeth, Light activation for bleaching materials for teeth. | | | | | | | : : {2}------------------------------------------------ 02262 Conclusion: After analyzing both bench and user testing data, it is the conclusion of Kavo that the GENTLEray 980 Diode Laser System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. {3}------------------------------------------------ Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Kavo America % Intertek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087 OCT 2 6 2007 Re: K072262 Trade/Device Name: GENTLEray 980 Diode Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and and in dermatology Regulatory Class: II Product Code: GEX Dated: October 10, 2007 Received: October 11, 2007 Dear Mr. Lehtonen: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. {4}------------------------------------------------ Page 2 - Mr. Daniel W. Lehtonen This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/suport/index.html Sincerely yours, Mark A. Milkeron Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use 510(k) Number (if known): k022262 Device Name: GENTLEray 980 Diode Laser System Indications for Use: Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. The GENTLEray 980 Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flan Singgry, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Arlene A. Millerson (Division of General, Restorative, and Neurological Dev KO 72262 510(k) Number