(89 days)
Not Found
No
The summary describes a surgical diode laser system with microprocessor control and operating software, but there is no mention of AI or ML capabilities in the intended use, device description, or other sections.
Yes
The device is intended for surgical procedures, including ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissue, which directly treats medical conditions.
No
The device is described as a surgical laser system intended for use in procedures requiring ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissue. These are therapeutic, not diagnostic, actions.
No
The device description explicitly lists hardware components such as a laser console/cabinet, display panel, and footswitch, in addition to the operating software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The description and intended use of the PhotoMedex LaserPro systems clearly state they are used for surgical procedures involving the direct application of laser energy to soft tissue within the body (in vivo). They are used for actions like ablation, vaporization, excision, incision, hemostasis, and coagulation.
- Lack of Specimen Examination: There is no mention of the device being used to examine specimens outside of the body.
Therefore, the PhotoMedex LaserPro 810, 940, and 980 Surgical Diode Laser Systems are surgical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are intended for delivery of laser light in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are generally indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, hemostasis or coagulation of soft tissue in surgical procedures in medical specialties including: dermatology, gastroenterology, general surgery (including specific treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein), genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems are designed to provide laser power at wavelengths of 810nm, 940nm, and 980mm, depending on model, which can be used for the procedures indicated in the next section of this summary . The system is comprised of the following main components:
- A laser console/cabinet with fiber port to accept SMA-905 connectors. .
- Display panel with soft-touch keypad control and separate Emergency Off . button.
- Laser system microprocessor control electronics with operating software .
- A detachable covered footswitch. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
MAY - 5 2004
510(k) SUMMARY
PhotoMedex, Inc.
LaserPro 810, 940 and 980 Systems Dioxide Laser Systems
1. GENERAL
| • | Submitter: | PhotoMedex, Inc. |
|---|---|---|
| 147 Keystone Drive | ||
| Montgomeryville, PA, 18936 |
- Bob Rose Contact Person: .
- February 2, 2004 Date Prepared: .
DEVICE NAME 2.
- · Classification name: Lascr surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810)
- Common or usual name: Diode laser .
- Trade or proprietary name: LascrPro Diode Surgical Laser System .
3. PREDICATE DEVICES
Diode Surgical Laser Systems
- Diomed D15 & D30 Laser Systems (K023543) .
- Premier Aurora Laser System (K954316) .
- SI.T Thermalite 810, 940 & 980 Laser Systems (K952661) .
4. DEVICE DESCRIPTION
The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems are designed to provide laser power at wavelengths of 810nm, 940nm, and 980mm, depending on model, which can be used for the procedures indicated in the next section of this summary . The system is comprised of the following main components:
- A laser console/cabinet with fiber port to accept SMA-905 connectors. .
- Display panel with soft-touch keypad control and separate Emergency Off . button.
- Laser system microprocessor control electronics with operating software .
- A detachable covered footswitch. .
1
5. INDICATIONS FOR USE
The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems (and the fiber delivery systems and accessories that are used with them 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), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, orthopedics, podiatry, pulmonology, and thoracic surgery.
6. SUBSTANTIAL EQUIVALENCE
The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems, when used in conjunction with cleared delivery accessories, share the same indications for use, similar design features, functional features, and therefore are substantially equivalent to the predicate devices which includes the Diomed D15 & D30 Laser Systems (K023543), the Premier Aurora Laser System (K954316), and the SLT Thermalite 810, 940 & 980 Laser Systems (K952661).
7. SAFETY AND EFECTIVENESS
The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems are designed, tested and manufactured in accordance with both mandatory and voluntary Standards ensuring when used with marketed cleared delivery systems identified to be compatible, they are considered both safe and effective for the medical applications indicated. No new clinical indications are to be provided by the introduction of LaserPro Diode Surgical Lasers as compared to the identified predicates, which have previously demonstrated clinical effectiveness.
8. CONCLUSIONS
Based on the information reviewed and provided within this application, PhotoMedcx believes that the LaserPro 810. 940 and 980 Diode Laser Systems are substantially equivalent to, and are safe and effective as the legally marketed identified predicate devices, the Diomed D15 & D30 Laser Systems (K023543), Premier Aurora Laser System (K954316), and the SLT Thermalite 810, 940 & 980 Laser Systems (K952661), in that they share the same mechanisms for laser energy delivery and indications for use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three parallel lines that curve and flow together, resembling a bird in flight or a symbolic representation of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2004
Mr. Bob Rose Director of Regulatory Affairs PhotoMedex, Inc. 147 Keystone Drive Montgomeryville, Pennsylvania 18936
Re: K040294
Trade/Device Name: LaserPro® 810, 940, and 980 Surgical Diode Laser Systems 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: February 5, 2004 Received: February 6, 2004
Dear Mr. Rose:
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 for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered prox to may 2011 - 11:45 accordance with the provisions of the Federal Food, Drug, de nees that have been require approval of a premarket approval application (PMA). and Coometter Free) 110) xxx the device, subject to the general controls provisions of the Act. The I ou may, aterer or , mains 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 (sec 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 docs not mean r hat 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 Crici are on your may (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 - Mr. Bob Rose
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in you ve FDA finding of substantial equivalence of your device to a legally premits to the neations 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 n you doch office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,
Miriam C. Provoost
Colia M. Witten, Ph.D., M.D. 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): K040294
Device Name: LaserPro® 810, 940 and 980 Surgical Diode Laser Systems
Intended Use/Indications For Use:
The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are intended for delivery of laser light in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are generally indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, hemostasis or coagulation of soft tissue in surgical procedures in medical specialties including: dermatology, gastroenterology, general surgery (including specific treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein), genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery.
Muriam C. Provost
Division of General. Restorative, ver-The-Counter Use Prescription Use
(21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
510(k) Number_________________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)