ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050
Device Facts
| Record ID | K050453 |
|---|---|
| Device Name | ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050 |
| Applicant | Ivoclar Vivadent, Inc. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | May 27, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The device is intended to be used for a variety of surgical procedures on soft tissue within the oral cavity. Dental Soft Tissue Indications: Sulcular debridement of diseased or fibrous tissue Excision and biopsy Gingivectomy and gingivoplasty Lesion (tumor) removal Fibroma removal Tissue retraction (troughing) Aphthous ulcers Gingival hyperplasia (excision and recontour) Crown Lengthening Operculectomy Frenectomy Photocoagulation Laser Periodontal procedures, including: 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 and junctional epithelium.
Device Story
Odyssey 2.4G Diode Laser delivers 810nm laser energy for oral soft tissue surgery; max 5W output. System uses solid-state diode; energy transmitted via proprietary optical fiber to metal handpiece with disposable single-use tips. Operator controls power and pulse settings; activation via foot-switch. Used in dental clinics by professionals. Provides precise tissue cutting/ablation; benefits include reduced bleeding and controlled tissue removal during periodontal or surgical procedures.
Clinical Evidence
Bench testing only. No clinical data provided. Compliance with 21 CFR 1040.10, 1040.11, IEC 60601-1:1998+A1, IEC 60601-2-22:1995, and FCC Part 15 verified.
Technological Characteristics
810±20nm solid-state diode laser; 5W max output; fiber optic delivery; fan-cooled; 630-650nm aiming beam; digital emission control; 100-240 VAC power. Complies with IEC 60601-1, IEC 60601-2-22, and 21 CFR 1040.10/11.
Indications for Use
Indicated for dental, oral, and soft tissue surgery in patients requiring soft tissue procedures, including sulcular debridement, excision, biopsy, gingivectomy, gingivoplasty, lesion/fibroma removal, tissue retraction, aphthous ulcer treatment, gingival hyperplasia recontouring, crown lengthening, operculectomy, frenectomy, photocoagulation, and periodontal soft tissue curettage.
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
- LaserSmile (K030539)
- DenLaser 800 (K003541)
- Opus 10 Dental Diode Laser (K000990)
- Aurora SL Diode Laser (K993285)
Related Devices
- K062258 — GENESIS DIODE LASER · Ivoclar Vivadent, Inc. · Mar 21, 2007
- K113472 — PRECISE SHP DIODE LASER · CAO Group, Inc. · Aug 30, 2012
- K061366 — DENLASER 800 PLUS · CAO Group, Inc. · Jul 10, 2006
- K142223 — Pilot Pro Diode Laser · CAO Group, Inc. · Sep 12, 2014
- K160413 — Sterling 5W Diode Laser · CAO Group, Inc. · Sep 21, 2016
Submission Summary (Full Text)
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November 3, 2021
Ivoclar Vivadent, Inc. Donna Harnett Director 175 Pineview Dr. Amherst, New York 14228
Re: K050453
Trade/Device Name: Odyssey 2.4g, Denlaser Elite, Model 002-00050 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
Dear Donna Harnett:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 27, 2005. Specifically, FDA is updating this SE Letter as an administrative correction. A second product code was inadvertently included.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Michael Adjodha, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-6276. Michael. Adjodha@fda.hhs.gov.
Sincerelv.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director for Restorative and Surgical Dental Devices DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the symbol of the United States Department of Health and Human Services, which is an abstract image of an eagle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, INC." is written around the edge of the circle. The text is written in a small, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 2005
Ms. Donna Marie Hartnett Director of QA/ Regulatory Affairs and Assistant Corporate Counsel Ivoclar Vivadent Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K050453
Trade/Device Name: ODYSSEY 2.4G DIODE LASER Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX, LYB Dated: February 15, 2005 Received: February 22, 2005
Dear Ms. Hartnett:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assessment the 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 rou may, arerers, maxis of the Act include requirements for annual registration, listing of general vontrols profice, labeling, and prohibitions against misbranding and adulteration.
ff 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 it may be sucjoct to bash 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 r rease oe advisou that I Dr. Brosan that your device complies with other requirements of the Act that : 19 ederal statutes and regulations administered by other Federal agencies. You must or any I cactar statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI R rate 077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by over sions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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#### Page 2 – Ms. Donna Marie Hartnett
This letter will allow you to begin marketing your device as described in your Section 510(k) This icher wifi anow you to organ manies of substantial equivalence of your device to a legally premation notification - 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 If you desire specific advice for your acon 15 . Also, please note the regulation entitled, Colliation of Complians at (210) = i 6 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Misolanding by reference to premaritor nibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Colisal http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Rela
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known): K050453
Device Name: ODYSSEY 2.4G DIODE LASER Indications For Use:
Dental Soft Tissue Indications:
Dental, oral and soft tissue surgery including:
Sulcular debridement of diseased or fibrous tissue Excision and biopsy Gingivectomy and gingivoplasty Lesion (tumor) removal Fibroma removal Tissue retraction (troughing) Aphthous ulcers Gingival hyperplasia (excision and recontour) Crown Lengthening Operculectomy Frenectomy Photocoagulation
Laser Periodontal procedures, including:
Laser soft tissue curettage Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket penoval of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.
Prescription Use __ _ _ _ AND/OR (Part 21 CFR 801 Subpart D)
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) |
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Testorative
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#### MAY 2 7 2005
#### 510(k)
## Summary of Safety and Effectiveness
Ivoclar Vivadent, Inc. 175 Pineview Dr., Amherst, NY 14228 Tel: 716-691-0010 Fax: 716-691-2294
Donna Hartnett, Director of QA/Regulatory Affairs Preparation Date: May 16, 2005
#### Device Name:
| Trade Name: | Odyssey™ 2.4G Diode Laser |
|-------------------------|-------------------------------------|
| Common Name: | 810nm Diode Laser |
| Product Classification: | Laser Instrument, Surgical, Powered |
## Legally Marketed Predicate Devices for Substantial Equivalence:
LaserSmile, Manufactured by BioLase Technology, Inc. (K030539)
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DenLaser 800, Manufactured by CAO Group, Inc. (K003541)
Opus 10 Dental Diode Laser, Manufactured by OpusDent, Inc. (K000990)
Aurora SL Diode Laser, Manufactured by Premier Laser Systems, Inc. (K993285).
#### Rationale for Substantial Equivalence:
The aforementioned laser devices and their accompanying delivery systems share similar indications for use in the oral environment, similar design features including wavelength, mulcations for use in allo off. The devices share similar methods of control operating controls, and neer den 1007
systems, safety features, and performance monitoring. The devices share similar performance specifications including power output and energy type.
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## Description of Submitted Device:
The Odyssey 2.4G Diode Laser is a device for delivering laser energy to surfaces within the Odyssey 2.40 Diode Lase is a dones for a do not to reasons of crowth orovide a consistent and the oral cavity. This ellergy is generation of bonus chooming of 5 watts of energy output.
reliable generation of laser energy at 810 ± 20nm for a maximum of 5 water reliable generation of last chergy at 010 = 2016. 10. and 10. a proprietary optical fiber system,
The laser energy is delivered to the surgical site by means of a proprietary I he laser energy is defrected to the safe the site without creating undue risk to which allows for the sale transmission or collateral laser emissions. The device features some the patient of operatory start of certail of conceral hast since and adjustable power output for user demiable settings, mending a swittenant of thinks of there or pulse delivery options.
The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use of the denvery noor so commission with the device. Activation of the disposative single ass tap ompleted by use of a foot-activated switch.
## Intended Uses of the Odyssey 2.4G Diode Laser:
The device is intended to be used for a variety of surgical procedures on soft tissue within the oral cavity.
Dental Soft Tissue Indications:
- Sulcular debridement of diseased or fibrous tissue Excision and biopsy Gingivectomy and gingivoplasty Lesion (tumor) removal Fibroma removal Tissue retraction (troughing) Aphthous ulcers Gingival hyperplasia (excision and recontour) Crown Lengthening Operculectomy Frenectomy Photocoagulation
Laser Periodontal procedures, including:
Laser soft tissue curettage Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket perfodomal pocket
Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium,
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# Technological Characteristics and Substantial Equivalence:
The DenLaser 800 uses solid state diodes to generate laser energy in the 810nm range. This system uses a fiber delivery system to transmit laser energy to the surgical site. The system of I his system uses a noer denvery system to transmit and that allow for adjusting the output of also leatures a 050mm animing between a continuous or pulsed-mode laser emission. The maximum output of the unit 5 watts.
The Opus 10 Diode Laser uses solid-state diodes to generate laser energy in the infrared region. The system features timing controls that allows for variation in duration or intervals of legion. This system fourses a 630-650nm aiming beam.
The Aurora Laser System uses solid-state diodes to generate laser energy in the infrared region. This system features similar power output, spot size, and equivalent pulse duration to that of the submitted device.
The LaserSmile System uses solid state diodes to generate laser energy in the infrared region. The system features similar power output to that of the submitted device.
#### Performance Standards:
The Odyssey 2.4G Diode Laser complies with the performance requirements of 21 CFR 1040.10 and 1040.11, with permissible deviations relative to Laser Notice 50, dated July 26, 10-0.10 and 10-0.11, with IEC 60601-1:1998+A1, IEC 60601-2-22:1995, and IEC 2001. The device also complies with FCC regulations Part 15 for wireless devices.
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# PERFORMANCE DATA - Comparison Table
| | Ivoclar Vivadent, Inc.<br>Odyssey 2.4G Diode<br>Laser | CAO Group, Inc.<br>DenLaser 800 | OpusDent, Inc.<br>Opus 10 Dental<br>Diode Laser | Premier Laser<br>Systems, Inc.<br>Aurora SL Diode<br>Laser | LaserSmile<br>Diode Laser<br>Biolase<br>Technology,<br>Inc. |
|-----------------------|-------------------------------------------------------|--------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| Wavelength | 810±20 nm | 810±20 nm | 810 nm | 810 nm | 810nm |
| Power | 5 watts | 5 watts | 10 watts | Unavailable | 10 watts |
| Aiming Beam | 630-650 nm, 3mW | 630-650 nm, 3mW | 630-680 nm,<br>power unavailable | 630-680 nm,<br>power unavailable | 630-670 nm |
| Cooling System | Fan air cooled | Fan air cooled | Fan air cooled | Fan air cooled | Fan air cooled |
| Pulse Control | Digital emission<br>control | Digital emission<br>control | Digital emission<br>control | Digital emission<br>control | 20 ms-9.9 sec |
| Laser Source | Solid-state diode | Solid-state diode | Solid-state diode | Solid-state diode | Solid-state<br>diode |
| Power<br>Requirements | 100-240 VAC @ 50-<br>60 Hz, 1.5A<br>(switchable) | 100-240 VAC @<br>50-60 Hz, 1.5 A<br>(switchable) | 110-120VAC @<br>50-60 Hz, 2.0A or<br>220-240VAC @<br>50-60 Hz, 1.2A | 115VAC @ 50-60<br>Hz, 0.8A<br>Info on 220VAC<br>unavailable | Not available |
| Dimensions | 10" x 8" x 4" | 10" x 8" x 4" | unavailable | 12" x 12" x 6" | 8.5" x 9" x<br>12.5" |
| 510(k) Number | Pending this<br>application | K003541 | K000990 | K993285 | K030539 |
#### Conclusion
The Odyssey 2.4G Diode Laser is substantially equivalent to the listed laser surgical devices without raising any issues of safety or effectiveness. This device shares similar intended devices without raising any issues of baracteristics. The device is designed to comply uses, and similar ranscroninternational safety and performance standards.
