(69 days)
Not Found
No
The device description focuses on the hardware components and basic operational modes (power output, continuous/pulsed operation) of a diode laser system. There is no mention of AI or ML in the intended use, device description, or the specific sections for AI/ML information.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is used for various medical and dental procedures, such as "incision, excision, vaporization, ablation and coagulation of oral soft tissues," "Treatment of canker sores," "Laser Periodontal Procedures," and "Teeth Whitening Procedures." These are all therapeutic applications.
No
The device is described as a laser system for performing various surgical and therapeutic procedures on oral soft tissues, such as incision, excision, coagulation, and teeth whitening. It does not mention any function related to diagnosing diseases or conditions.
No
The device description clearly describes a hardware system including laser diodes, fiber optic cables, a handpiece, and a foot-switch, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- Device Function: The PROMETEY ™ diode laser system is a surgical laser used to directly treat tissues within the oral cavity. It performs procedures like cutting, vaporizing, and coagulating tissue. It does not analyze samples taken from the body.
- Intended Use: The intended uses listed are all direct treatments of oral soft tissues and teeth, not diagnostic tests performed on specimens.
Therefore, based on the provided information, the PROMETEY ™ diode laser system is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to be used for a variety of surgical procedures in the oral cavity:
Dental Soft Tissue Indications for incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
Excision and Incision Biopsies, Hemostasis and Coagulation, Treatment of canker sores, herpetic and aphthous ulcers, Frenectomy and Frenotomy, Gingival Incision and Excision, Gingivectomy and Gingivoplasty, Incision and Drainage of Abscess, Operculectomy, Oral Papillectomy, Removal of Fibromas and Hyperplastic tissues, Exposure of un-erupted / partially erupted teeth, Implant recovery, Tissue retraction / troughing, Leukoplakia, Pulpotomy, Soft tissue crown lengthening, Vestibuloplasty.
Laser Periodontal Procedures, including:
Laser soft tissue curettage, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility).
Teeth Whitening Procedures, including:
Light Activation of bleaching materials for teeth whitening, Laser-assisted whitening / bleaching of teeth.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The PROMETEY ™ diode laser system is a device for delivering laser power to treated surfaces within oral cavity. This power is produced by solid-state laser diodes, which provide a consistent generation of laser power in 810 ± 10 nm spectral region with maximum power of 3 Watts. The laser power is delivered to the treatment site by means of fiber optic cables available in 400, 300 and 200 um core diameters. These cables provide safe transmission of laser power to the surgical site without creating undue risk to a patient or operatory staff by errant or collateral laser emissions. The device features front-panel keypad used to activate 650 nm aiming beam, set power output and select continuous or pulsed operation mode.
The distal end of delivery fiber cable is contained within a metal handpiece with a disposable tip /cannula. A standard foot-switch controls initiation /termination of laser power from the delivery fiber.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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.
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.
0
K 062071
510(k) Summary of Safety and Effectiveness Information
| Company: | Spectrum International, Inc.
2643 Pleasant Hill Road
Pleasant Hill, CA 94523
Phone / fax: (925)798-8913 |
|------------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | George I. Bekov, President
Phone: (925)768-1122, fax: (925)798-8913 |
| Preparation Date: | July 17, 2006 |
| Device Name: | |
| - Trade name: | PROMETEY TM |
| - Common name: | Soft tissue diode laser |
| - Classification name: | Laser instrument, Surgical, Powered |
| - Product code: | GEX |
Legally Marketed Predicate Devices for Substantial Equivalence:
| - | K050453 | Odyssey 2.4G | by Ivoclar Vivodent, Inc. |
|---|---|---|---|
| - | K030539 | LaserSmile | by BioLase Technology, Inc. |
| - | K021227 | SoftLase | by ZAP Lasers, LLC |
Description of Submitted Device:
The PROMETEY ™ diode laser system is a device for delivering laser power to treated surfaces within oral cavity. This power is produced by solid-state laser diodes, which provide a consistent generation of laser power in 810 ± 10 nm spectral region with maximum power of 3 Watts. The laser power is delivered to the treatment site by means of fiber optic cables available in 400, 300 and 200 um core diameters. These cables provide safe transmission of laser power to the surgical site without creating undue risk to a patient or operatory staff by errant or collateral laser emissions. The device features front-panel keypad used to activate 650 nm aiming beam, set power output and select continuous or pulsed operation mode.
The distal end of delivery fiber cable is contained within a metal handpiece with a disposable tip /cannula. A standard foot-switch controls initiation /termination of laser power from the delivery fiber.
Intended Use of PROMETEY Soft Tissue Diode Laser:
The device is intended to be used for a variety of surgical procedures in the oral cavity:
Dental Soft Tissue Indications for incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
Excision and Incision Biopsies, Hemostasis and Coagulation, Treatment of canker sores, herpetic and aphthous ulcers, Frenectomy and Frenotomy, Gingival Incision and Excision,
SEP 2 8 2006
1
Gingivectomy and Gingivoplasty, Incision and Drainage of Abscess, Operculectomy, Oral Papillectomy, Removal of Fibromas and Hyperplastic tissues, Exposure of un-erupted / partially erupted teeth, Implant recovery, Tissue retraction / troughing, Leukoplakia, Pulpotomy, Soft tissue crown lengthening, Vestibuloplasty.
Laser Periodontal Procedures, including:
Laser soft tissue curettage, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility).
Teeth Whitening Procedures, including:
Light Activation of bleaching materials for teeth whitening, Laser-assisted whitening / bleaching of teeth.
Technological Characteristics of Submitted and Predicate Diode Lasers and Substantial Equivalence:
| Feature | Prometey | Odyssey 2.4G | LaserSmile | SoftLase |
|---|---|---|---|---|
| 510(k) Number | This application | K050453 | K030539 | K021227 |
| Wavelength | $810 \pm 10$ nm | $810\pm 20$ nm | 810 nm | $808 \pm 5$ nm |
| Max Power | 3 Watts | 5 Watts | 10 Watts | 3.5 Watts |
| Operation mode | Continuous | |||
| wave | ||||
| and pulsed | Continuous | |||
| wave | ||||
| and pulsed | Continuous wave | |||
| and pulsed | Continuous | |||
| wave | ||||
| and pulsed | ||||
| Pulse control | Digital | |||
| emission control | Digital | |||
| emission control | Digital | |||
| emission control | Digital | |||
| emission control | ||||
| Laser | ||||
| power source | Solid-state diode | Solid-state diode | Solid-state diode | Solid-state diode |
| Aiming beam laser | 630-650 nm, 2 mW | 630-650 nm, 3 mW | 630-670 nm, 5 mW | 650nm, 5 mW |
| Delivery system | Multi-mode fiber | |||
| 400, 300, 200 um | Multi-mode fiber | |||
| 400 um | Multi-mode fiber | |||
| 1000-300 um | Multi-mode fiber | |||
| 600, 400 um | ||||
| Power | ||||
| requirements | 100-240 VAC, 50- | |||
| 60Hz, 0.5 A | 100-240 VAC, 50- | |||
| 60Hz, 1.5 A | 100-240 VAC, 50- | |||
| 60Hz, 1.5 A | 100-240 VAC, 50- | |||
| 60Hz, 1.0 A | ||||
| Cooling system | Fan / air cooled | Fan / air cooled | Fan / air cooled | Fan / air cooled |
Comparison Table
The aforementioned diode laser devices and their delivery systems share similar indications for use in oral environment, similar design features including wavelength, operating controls, and laser power delivery method. The devices share similar methods of control systems, safety features, and performance monitoring. The devices share similar performance specifications except for maximum power output, which is the lowest for Prometey laser but is still enough to perform all Indications for Use since their laser power requirements are below 3 Watts.
2
Summary Basis of Equivalence:
There are no unique applications, indications for use, materials or specifications presented herein. Evidence of substantial equivalence has been demonstrated through:
- The PROMETEY ™ intended use and indications for use were previously cleared by . FDA for the predicate devices.
- The technical characteristics of Prometey diode laser are similar to those of cleared . Odyssey 2.4G, LaserSmile and SoftLase diode laser systems.
- Laser power output values of Prometey are well within previously cleared values of . predicate dental laser systems as described.
- The predicate devices and other previously FDA cleared diode laser systems with . similar power outputs have a proven safety and effectiveness in the treatment of the claimed indications.
- Safety and performance testing. .
Therefore, the PROMETEY ™ soft tissue diode laser system is substantially equivalent to its predicate devices cited above and raises no new safety and/or effectiveness issues. The device is designed to fully comply with relevant federal and international safety and performance standards.
3
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 2006
Spectrum International, Inc. % Mr. George I. Bekov President 2643 Pleasant Hill Road Pleasant Hill, California 94523
Re: K062071
Trade/Device Name: PROMETEY™ 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 Dated: July 17, 2006 Received: July 24, 2006
Dear Mr. Bekov:
This letter corrects our substantially equivalent letter of September 28, 2006.
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 (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 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
4
Page 2 - Mr. George I. Bekov
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.
This letter will allow you to continue 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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Neil R.P. Ogden
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): K 86 207 PROMETEY TM
Device Name:
Indications for Use:
Dental Soft Tissue Indications for incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
Excision and Incision Biopsies. Hemostasis and Coagulation. Treatment of canker sores. herpetic and aphthous ulcers, Frenectomy and Frenotomy, Gingival Incision and Excision, Gingivectomy and Gingivoplasty, Incision and Drainage of Abscess, Operculectomy, Oral Papillectomy, Removal of Fibromas and Hyperplastic tissues, Exposure of un-erupted / partially erupted teeth, Implant recovery, Tissue retraction / troughing, Leukoplakia, Pulpotomy, Soft tissue crown lengthening, Vestibuloplasty.
Laser Periodontal Procedures, including:
Laser soft tissue curettage. Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility).
Teeth Whitening Procedures, including:
Light Activation of bleaching materials for teeth whitening, Laser-assisted whitening / bleaching of teeth.
| 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)
Mark N. Milken
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062071
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