(88 days)
Not Found
No
The description focuses on standard laser technology and does not mention any AI or ML capabilities.
Yes
The device is indicated for surgical applications such as ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues, which are all therapeutic procedures.
No
The device is described as a medical laser indicated for surgical applications such as ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues, which are all therapeutic procedures, not diagnostic ones.
No
The device description explicitly states that the devices are "standard diode medical lasers," which are hardware devices that emit laser light for surgical applications. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that the Fox Q-810, Q-980, and Q-1064 are medical lasers used for surgical applications directly on soft tissues within the body (ablation, vaporization, excision, etc.). They are not used to analyze samples taken from the body.
Therefore, these devices fall under the category of surgical lasers, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Fox Q-810:
indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology.
Fox Q-980:
indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.
Fox Q-1064:
indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, general surgery, genitourinary, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Fox Q-810, Q-980 and Q-1064 are standard diode medical lasers with 810, 980nm and 1064nm wavelength, respectively
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 (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
K073322
.
510(k) SUMMARY – Fox Q-810, Q-980 and Q-1064 Laser
| Applicant Name: | A.R.C. Laser GmbH
Bessemerstr. 14, D-90411 Nurnberg, Germany |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Reinhardt Thyzel, President |
| Date Prepared: | February 8, 2008 |
| Device Trade Name: | Fox Q-810, Q-980 and Q-1064 Lasers |
| Device Common Name: | Diode Laser |
| Classification Name: | Laser Surgical Instrument |
| Predicate Devices: | Fox Q-810 (K062619), Ceralas 980 (K072106) and
Laserscope 1064 (K990903) |
| Device Description: | Fox Q-810, Q-980 and Q-1064 are standard diode
medical lasers with 810, 980nm and 1064nm
wavelength, respectively |
| Intended Use: | Fox Q-810:
indicated for surgical applications requiring the ablation,
vaporization, excision, incision, hemostasis, or
coagulation of soft tissues in medical specialties
including dermatology, dentistry, gastroenterology,
general surgery, neurosurgery, otolaryngology,
ophthalmology, and pulmonology. |
| | Fox Q-980:
indicated for surgical applications requiring the ablation,
vaporization, excision, incision, hemostasis, or
coagulation of soft tissues in medical specialties
including dermatology, dentistry, gastroenterology,
general surgery, genitourinary, gynecology,
neurosurgery, otolaryngology, orthopedics, |
| Device Technological
Characteristics and
Comparison to Predicate
Device(s): | The Fox Q-980 uses diodes to generate energy in the
980 nm range. (Commercially available) Fibers deliver
energy to the tissue. The Fox Q-1064 Laser is the same
system, but generates energy in the 1064 nm range.
The new Fox Q-810 is also the same, producing energy
in the 810 nm range. |
| | Predicates: The Fox Q-810 Laser (cleared under
K062619) is the same system, but generates energy in
the 810 nm range (at a lower output than the new 810
nm device). The Ceralas 980 is also a diode laser
producing energy in the 980 nm range, and the
Laserscope system produces energy in the 1064 nm
range. |
| Performance Standards: | The Fox Q-810, Q-980 and Q-1064 Lasers comply 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 lasers also
comply 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 810, 980 and 1064 Lasers are substantially
equivalent to the predicate devices. They have similar
intended uses and comply with the same safety and
performance standards. |
1
ophthalmology, pulmonology, and thoracic surgery.
Fox Q-1064:
indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, general surgery, genitourinary, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design.
FEB 22 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
A.R.C. Laser GmbH % PPD Medical Device Ms. Kirsten H. Paulson 3202 Tower Oaks Blvd. Rockville, MD 20852
Re: K073322 Trade/Device Name: Fox 1-980, Fox Q-1064, Fox Q-810 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: November 21, 2007 Received: November 26, 2007
Dear Ms. Paulson:
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.
3
Page 2 - Ms. Kirsten H. Paulson
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 yours,
Mark N Millican
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K073322
Device Name: Fox Q-810, Q-980 and Q-1064 Diode Laser Indications for Use:
Image /page/4/Picture/3 description: The image shows a document with a signature and some text. The signature appears to read "Mark A Miller". Below the signature, the text indicates that this is a "Division Sign-Off" for the "Division of General, Restorative, and Neurological Devices". The 510(k) Number is listed as K073322.
Fox Q-810:
indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology , general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology .
Fox Q-980:
indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.
Fox Q-1064:
indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, general surgery, genitourinary, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.
| Prescription Use X | AND/OR | Over-The-Counter Use _ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)