(254 days)
Not Found
No
The document describes a standard CO2 laser system for surgical applications and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue, which are therapeutic medical procedures.
No
Explanation: The device is indicated for surgical applications such as ablation, vaporization, excision, incision, and coagulation of soft tissue. These are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a CO2 Medical Laser System with physical components like a laser, oscillation system, and light guiding system, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue." This describes a device used on the patient's body for treatment, not a device used to test samples from the patient's body to diagnose a condition.
- Device Description: The description details a CO2 laser system designed for surgical procedures, focusing on its technical specifications for delivering laser energy. This aligns with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
In summary, the Opelaser Family is a surgical laser system used for treating soft tissue, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Opelaser Family is CO2 Medical Laser Systems (and the delivery system that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.
Product codes
GEX
Device Description
These are CO2 Laser devices designed for surgical applications. The maximum power output for the PRO model is 7 watts, and for the LITE model, 5 watts. Type of laser is a CO2 gas laser (class 4); Oscillation system: RF discharge excitation oscillation; Light guiding system: SiO2 hollow fiber or 6 point articulated arm depending on model; Oscillation wavelength: 10.6um.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The OPELASER systems have undergone extensive safety and bench testing as well as software validation and risk analysis. The ability to sterilize the laser tips has been validated. The OPELASER systems have been tested and certified by the NRTL (Nationally Recognized Test Lab) Intertek. Certification to IEC/UL 60601-1 and IEC 60601-1-22 has been accomplished. The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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510(K) Summary, 510(k) K120932 Submitter: DEC 7 2012 THE YOSHIDA DENTAL MFG. CO., LTD 1-3-6 Kotobashi, Sumida-ku Tokyo, Japan ZIP 130-8516 TEL: +81-3-3631-2165 (International Business Div.) FAX: +81-3-3631-2685 (International Business Div.) Contact: Hidenori Watanabe, Regulatory Affairs, hi-watanabe@yoshida-net.co.jp Date Prepared: March 15, 2012
1. Identification of the Device:
Proprietary-Trade Name: OPELASER PRO II and OPELASER Lite II Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Product Code GEX Common/Usual Name: Powered laser surgical instrument
- Equivalent legally marketed devices: K031440, DEKA, Model Smart US 20D; K030147 2. Lumenis Model: UltraPulse SurgiTouch
- Description of the Device: These are CO2 Laser devices designed for surgical applications. The 3. maximum power output for the PRO model is 7 watts, and for the LITE model, 5 watts. Type of laser is a CO2 gas laser (class 4); Oscillation system: RF discharge excitation oscillation; Light guiding system: SiO2 hollow fiber or 6 point articulated arm depending on model; Oscillation wavelength: 10.6um.
- Indications for Use. The Opelaser Family is CO2 Medical Laser Systems (and the delivery system 4. that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.
- Safety and Effectiveness, comparison to predicate device. This device has the same indications 5. for use as the predicate device and employs nearly identical technology to accomplish the same task. Delivered energy levels and wavelengths are essesntially the same.
- Description of Testing, nonclinical tests submitted: The OPELASER systems have undergone 6. extensive safety and bench testing as well as software validation and risk analysis. The ability to sterilize the laser tips has been validated. The OPELASER systems have been tested and certified by the NRTL (Nationally Recognized Test Lab) Intertek. Certification to IEC/UL 60601-1 and IEC 60601-1-22 has been accomplished.
- Substantial Equivalence: A detailed comparison of specifications and technologies, as well as 7. comparisons of indications for use shows that the OPELASER device are substantially equivalent to the predicate devices. Safety standards applied are the same, as well.
- The conclusions drawn from the nonclinical and clinical tests demonstrate that the 8. Conclusion: device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph 2, above.
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Exhibit 6. Truthful and Accuracy Statement as required per 21CFR807.87(k).
I certify that, in my capacity as Executive Chief Operating Officer of the Laser division of The Yoshida Dental Mfg. Co., Ltd., I believe, to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate, and that no material fact has been omitted.
高橋三浄
(Signature)
Mioki Hirohashi Date: March 13, 2012
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure embracing a sphere, symbolizing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem. The logo is presented in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service .
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002
December 7, 2012
The Yoshida Dental Mfg. Co., Ltd. % Kamm and Associates Mr. Daniel Kamm 8870 Racello Court Naples, Florida 34114
Re: K120932
Trade/Device Name: Opelaser Pro II and Opelaser Lite II 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
Dated: November 29, 2012 Received: December 03, 2012
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have and have 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
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Page 2 – Mr. Daniel Kamm
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -Si 2012.12.07 17:09:12 -05'00'
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K120932
Device Name: QPELASER PRO II and OPELASER Lite II
Indications For Use:
The Opelaser Family is CO2 Medical Laser Systems (and the delivery system that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.
Prescription Use _X (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)
AND/OR
Neil R Ogden
2012.12.07 16:46:19 -05'00'
(Division Sign-Off) for MXM
Division of Surgical Devices
510(k) Number