(117 days)
Not Found
No
The provided text describes a laser system for surgical applications and does not mention any AI or ML components or functionalities.
Yes
The device is described as a laser system intended for surgical applications requiring ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues, as well as laser-assisted lipolysis, which are all therapeutic functions.
No
Explanation: The device is described as a laser system for surgical applications like ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is a "diode laser system," which is a hardware component. The intended use also describes a physical intervention (laser assisted lipolysis, ablation, vaporization, etc.) performed by this hardware.
Based on the provided information, the NaturaLase 980 Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes surgical applications on soft tissues within the body (in vivo). IVD devices are used to examine specimens taken from the body (in vitro).
- Device Description: The device is a laser system that delivers light for surgical procedures. IVD devices typically involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components of an IVD device.
Therefore, the NaturaLase 980 Laser System is a surgical laser device, not an IVD.
N/A
Intended Use / Indications for Use
NaturaLase 980 Laser System is intended for laser assisted lipolysis. The NaturaLase 980 Laser System is intended for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, plastic surgery, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, orthopedics, pulmonology, thoracic surgery arthroscopy and podiatry.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ORK
Device Description
The NaturaLase 980 Laser System is a diode laser system with 980 nm wavelength light.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
soft tissues
Indicated Patient Age Range
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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
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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.
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
4. 510(K) SUMMARY
This 510 (k) summary of safety and effectiveness for the Focus Medical NaturaLase 980 Laser System is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510 (k) summary.
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
| Applicant: | Focus Medical
23 Francis J. Clarke Circle
Bethel, CT 06801
203-730-8885 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Focus Medical
23 Francis J. Clarke Circle
Bethel, CT 06801 |
| Contact Person: | Mr. John B. Lee, Jr.
President
Focus Medical |
| Name of the Device: | NaturaLase 980 Laser System |
| Predicate Devices: | This is device is substantially equivalent to:
Osyris Pharaon Lipo (K073617)
PhotoMedex LaserPro (K082721) |
| Device Description: | The NaturaLase 980 Laser System is a diode laser
system with 980 nm wavelength light. |
| Indications for Use: | NaturaLase 980 Laser System is intended for laser
assisted lipolysis. The NaturaLase 980 Laser System is
intended for surgical applications requiring the ablation,
vaporization, excision, incision, hemostasis, or
coagulation of soft tissues in medical specialties including
dermatology, plastic surgery, dentistry, gastroenterology,
general surgery, genitourinary, gynecology,
neurosurgery, otolaryngology, orthopedics,
ophthalmology, orthopedics, pulmonology, thoracic
surgery arthroscopy and podiatry. |
| Conclusion: | The specifications, indications for use and performance
of the NaturaLase 980 Laser System is substantially
equivalent to the legally marketed predicate devices. It
raises no new issues of safety and effectiveness and
should be approved for marketing under the general
controls provisions of the Federal Food, Drug, and
Cosmetic Act. |
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the department's emblem, which is a stylized caduceus. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Focus Medical, LLC % Mr. John B. Lee, Jr. President 23 Francis J. Clarke Circle Bethel, Connecticut 08801
AUG 1 8 2010
Re: K101152
Trade/Device Name: NaturaLase 980 Laser System 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, ORK Dated: July 26, 2010 Received: July 27, 2010
Dear Mr. Lee:
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. 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.
2
Page 2 - Mr. John B. Lee. Jr.
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); 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Molkeraan
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3. INDICATIONS FOR USE STATEMENT
510(k) Number: K101152
Device Name: NaturaLase 980 Laser System
Indications For Use:
NaturaLase 980 Laser System is intended for laser assisted lipolysis. The NaturaLase 980 Laser System is intended for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, plastic surgery, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, orthopedics, pulmonology, thoracic surgery arthroscopy and podiatry.
Prescription Use × (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) The
Neil Mc Oghen for mxm
(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K101152