(26 days)
Not Found
No
The document describes a laser system with specific wavelengths and power outputs for dental procedures, with no mention of AI or ML capabilities.
No
A therapeutic device is one that treats a disease or condition. This device is intended to aid during dental procedures for purposes such as removal, preparation, etching, vaporization, excision, and coagulation, which are procedural steps rather than direct treatment modalities for a disease or condition.
No
The device description and intended use state that the OpuDuo Dental Laser System is intended to aid during dental procedures and is indicated for caries removal, cavity preparation, enamel etching, and vaporization, excision and coagulation of oral soft tissue. These functions are all therapeutic or procedural in nature, not diagnostic.
No
The device description explicitly states it is a "dual laser system incorporating an Er: Y AG laser and a CO2 laser," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for aiding in dental procedures performed on hard or soft oral tissue. This involves direct interaction with the patient's body for treatment purposes.
- Device Description: The description details a laser system that delivers energy to tissue for procedures like caries removal, cavity preparation, vaporization, excision, and coagulation. These are all therapeutic or surgical interventions.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device operates in vivo (within the body) for treatment.
N/A
Intended Use / Indications for Use
The OpuDuo Dental Laser System is intended to aid during dental procedures performed either in hard or soft oral tissue.
The Er: YAG laser component is indicated for caries removal, cavity preparation, and enamel etching.
The CO2 laser component is indicated for vaporization, excision and coagulation of oral soft tissue in procedures such as gingivectomy; frenum release; removal of soft tissue, cysts and tumors.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Opus Spectrum c is a model of the Opus 20 Dental Laser System which is intended to aid during dental procedure performed either in hard or soft oral tissue. This is a dual laser system incorporating an Er: Y AG laser and a CO2 laser. The system is operating at a wavelength of 2.94 microns and 10.6 microns respectively. The Er:YAG laser delivers to the tissue pulses with energies up to 1 joule per pulse and power up to 12 Watts. . The CO2 laser delivers to the tissue power in continuous mode (CW) up to 10 Watts and pulses (SP) up to 6 Watts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral 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.)
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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.
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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
510(k) Summary
OpusDent Ltd.
Opus Spectrum
510(k) Number KO 14/00
1/3
Submitter's Name:
OpusDent Ltd. Atid Science Based industrial Park, Hagavish 4 St., Natania south P.O.Box 8737 Natania 42505, Israel Tel .: 972-9-892 3333 Fax: 972-9-892 3300
Contact Person:
Arava Hacohen Push-Med Ltd. 117, Ahuza St., Ra'ananna 43373, Israel Tel: 972-9-7718130 Fax: 972-9-7718131 e-mail: arava@push-med.com
Trade Name:
Opus Spectrum (a model of Opus 20)
Classification Name:
Laser Instrument, Surgical, Powered
Classification:
t
Laser Instrument, Surgical, Powered are class II devices (Product Code GEX).
Predicate Device:
The Opus Spectrum dental laser system is substantially equivalent to Opus 20 dental laser system (OpusDent Ltd, Israel) cleared under K002899.
Indication for use:
The OpuDuo Dental Laser System is intended to aid during dental procedures performed either in hard or soft oral tissue.
The Er: YAG laser component is indicated for caries removal, cavity preparation, and enamel etching.
1
43 K014160
The CO2 laser component is indicated for vaporization, excision and coagulation of oral soft tissue in procedures such as gingivectomy; frenum release; removal of soft tissue, cysts and tumors.
Device Description:
The Opus Spectrum c is a model of the Opus 20 Dental Laser System which is intended to aid during dental procedure performed either in hard or soft oral tissue. This is a dual laser system incorporating an Er: Y AG laser and a CO2 laser. The system is operating at a wavelength of 2.94 microns and 10.6 microns respectively. The Er:YAG laser delivers to the tissue pulses with energies up to 1 joule per pulse and power up to 12 Watts. . The CO2 laser delivers to the tissue power in continuous mode (CW) up to 10 Watts and pulses (SP) up to 6 Watts.
Substantial Equivalence:
The Opus Spectrum dental laser system is substantially equivalent to the Opus 20 dental laser system (OpusDent Ltd.). In fact, it is an improved model of Opus 20 that is similar to its predicate device except the following features:
- · Opus Spectrum software runs on Window NT® Operating System while Opus 20 incorporates a stand-alone software.
- · Opus Spectrum is controlled by a PC Computer (PCM-5820) while Opus 20 is controlled by an embedded CPU.
- · Opus Spectrum has a Touch-Screen technology instead of soft keys.
- · Opus Spectrum incorportes an On Line Monitor that monitors the Er:YAG lasing power in addition to the two power meters in Opus 20.
- · Opus Spectrum has two masts one for Er:YAG and one for CO2. Opus 20 has one mast for both lasers.
- · Additional safety feature was added to Opus Spectrum. A microswitch is located in each handpiece carrier to indicate the handpiece in use and to identify miscorrelation between handpiece and desired laser mode.
- · Opus Spectrum has external cooling system that cools the coolant of the internal cooling systems while Opus 20 has internal water/air cooling system.
- · Opus Spectrum incorporates a new power supply.
- · Opus Spectrum is smaller in size and it is half weight than Opus 20.
- · The external design of the Opus Spectrum differs from Opus 20.
2
K014/00 3/3
Design Control Activities Summary:
The risk analysis methods used to assess the impact of the modification on the device and its components, and the result of the analysis are presented in Section 4 of the submission.
Based on the risk analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied are presented in Sections 6 and 8 of this submission.
A declaration of conformity with design control is attached to Section 6 of this submission.
3
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a bird, possibly an eagle, with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 8 2002
OpusDent Ltd. c/o Mr. Arava Hacohen Project Manager Push-med Ltd. 117 Ahuza Street Ra'ananna 43373 Israel
Re: K014100 Trade/Device Name: Opus Spectrum Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general surgery and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: November 19, 2001 Received: December 13, 2001
Dear Mr. Hacohen:
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. Arava Hacohen
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
StipA. Rhodes
Julie M. Witten, Ph.D., M.D.
. Witten, Ph.D., M.D. Celia M Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number:
014100
Opus Spectrum Device Name:
Indications for Use:
The OpuDuo Dental Laser System is intended to aid during dental procedures performed either in hard or soft oral tissue.
The Er: YAG laser component is indicated for caries removal, cavity preparation, and enamel etching.
The CO2 laser component is indicated for vaporization, incision, excision and coagulation of oral soft tissue in procedures such as gingivectomy; frenum release; removal of soft tissue, cysts and tumors.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Thypt Church
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Prescription Use
(Per 21 CFR 801.109)
510(k) Number K014100
OR Over the Counter Use