(94 days)
Not Found
No
The device description focuses on the hardware components and basic user controls for delivering laser energy, with no mention of AI or ML capabilities for analysis, decision-making, or image processing.
Yes
The device is used for various dental, oral, and soft tissue surgical procedures, which are therapeutic interventions.
No
The device description and intended use indicate it is an energy delivery system for surgical procedures, not for diagnostic purposes.
No
The device description clearly outlines hardware components such as a solid-state diode, optical fiber system, metal handpiece, disposable tip, and foot-activated switch, indicating it is a hardware device that utilizes laser energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description clearly states that the Odyssey 2.4G Diode Laser is a device for delivering laser energy to surfaces within the oral cavity for various surgical procedures. It directly interacts with the patient's tissues in vivo.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any specimens from the patient. The device's function is to perform surgical interventions directly on the patient's soft tissues.
Therefore, the Odyssey 2.4G Diode Laser is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX, LYB
Device Description
The Odyssey 2.4G Diode Laser is a device for delivering laser energy to surfaces within the oral cavity. This energy is generated by solid-state diodes, providing a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 5 watts of energy output. The laser energy is delivered to the surgical site by means of a proprietary optical fiber system, which allows for the safe transmission without creating undue risk of collateral laser emissions. The device features an adjustable power output for user definable settings, and continuous wave or pulse delivery options.
The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. Activation of the device is completed by use of a foot-activated switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity / Dental, oral and 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)
Not Found
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.
K030539, K003541, K000990, K993285
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.
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a bold, sans-serif font and the full name, "U.S. Food & Drug Administration," written below in a smaller font.
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
1
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.
2
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) |
|---|
| -------------------------------------------------------- |
Page 1 of 1
Image /page/3/Picture/14 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text reads 'keso453' in a cursive style. The characters are written in black ink on a white background, and the handwriting is somewhat slanted.
Testorative
4
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)
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.
5
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,
6
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.
Odyssey 2.4G Diode
Laser | CAO Group, Inc.
DenLaser 800 | OpusDent, Inc.
Opus 10 Dental
Diode Laser | Premier Laser
Systems, Inc.
Aurora SL Diode
Laser | LaserSmile
Diode Laser
Biolase
Technology,
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,
power unavailable | 630-680 nm,
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
control | Digital emission
control | Digital emission
control | Digital emission
control | 20 ms-9.9 sec |
| Laser Source | Solid-state diode | Solid-state diode | Solid-state diode | Solid-state diode | Solid-state
diode |
| Power
Requirements | 100-240 VAC @ 50-
60 Hz, 1.5A
(switchable) | 100-240 VAC @
50-60 Hz, 1.5 A
(switchable) | 110-120VAC @
50-60 Hz, 2.0A or
220-240VAC @
50-60 Hz, 1.2A | 115VAC @ 50-60
Hz, 0.8A
Info on 220VAC
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
12.5" |
| 510(k) Number | Pending this
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.