(228 days)
Not Found
No
The summary describes a diode laser with a specific wavelength and power output, and there is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is used for surgical applications such as ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues, which are therapeutic interventions.
No
The device is described as a diode laser for surgical applications requiring ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues, which are all therapeutic functions, not diagnostic. There's no mention of detecting, monitoring, or predicting diseases or health conditions.
No
The device description explicitly states it is a "diode laser," which is a hardware component used for surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the Fox 940 is for surgical applications directly on soft tissues within the body (ablation, vaporization, excision, etc.).
- The device description is for a surgical laser. Lasers used for surgical procedures are not considered IVDs.
- There is no mention of analyzing biological samples. The information focuses on the physical interaction of the laser with tissue.
Therefore, the Fox 940 is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Fox 940 Diode Laser is indicated for: Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.
Product codes
GEX
Device Description
Fox 940 is a diode laser with 940 nM wavelength and maximum 5 watt power output.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 -- Fox 940 Laser
FEB 22
| Applicant Name: | Valam, Inc.
41 West 57th St. 6th Floor, New York, NY 10019 |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yosef Krespi, M.D. |
| Date Prepared: | February 4, 2008 |
| Device Trade Name: | Fox 940 Laser |
| Device Common Name: | Diode Laser |
| Classification Name: | Laser Surgical Instrument |
| Predicate Devices: | Fox 810 (K062619), LaserPro (K040924) |
| Device Description: | Fox 940 is a diode laser with 940 nM wavelength and
maximum 5 watt power output. |
| Intended Use: | Surgical applications requiring the ablation, vaporization,
excision, incision, hemostasis, or coagulation of soft
tissues in medical specialties including dermatology,
gastroenterology, general surgery, genitourinary,
gynecology, neurosurgery, otolaryngology, orthopedics,
ophthalmology, pulmonology, and thoracic surgery. |
| Device Technological
Characteristics and
Comparison to Predicate
Device(s): | The Fox 940 uses diodes to generate energy in the 940
nm range. Fibers deliver energy to the tissue. The Fox
810 Laser is the same system, but generates energy in
the 810 nm range. The LaserPro is also a diode laser
producing energy in the 940 nm range. |
| Performance Standards: | The Fox 940 Laser complies with the performance
requirements of 21CFR 1040.10 and 1040.11, with
permissible deviations defined in Laser Notice 50, dated
July 26, 2001. The diode laser also complies with IEC
60601-1:1998 including amendment 1, IEC 60601-2-
22:1995, and IEC 60825-1:1993 including amendments
1 and 2. |
| Conclusion: | The Fox 940 Laser is substantially equivalent to the
predicate devices. It has similar intended uses and
complies with the same safety and performance
standards. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
FEB 22 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Valam. Inc. % PPD Medical Device Ms. Kirsten Paulson Manager, Regulatory Affairs 3202 Tower Oaks Blvd, Suite 300 Rockville, Maryland 20852
K071896 Trade/Device Name: Fox 940 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: Class II Product Code: GEX Dated: December 07, 2007 Received: December 07, 2007
Dear Ms. Paulson:
Re:
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
2
Page 2 – Ms. Kirsten Paulson
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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/industry/support/index.html.
Sincerely vours.
Mark N Mulhurn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
| 510(k) Number (if known): | K071896 |
|---|---|
| Device Name: Fox 940 Diode Laser | |
| Indications for Use: |
The Fox 940 Diode Laser is indicated for:
Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
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)
Mark M. Milkesen
(Division Sign-Off) Division of General, Restorative, and Neurological Device
510(k) Number
Additional Information K071896 Page S