(87 days)
Not Found
Not Found
No
The device description details a standard laser system with user-controlled parameters and a system computer for interface, but makes no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is indicated for the "treatment" of pseudofolliculitis barbae, which is a therapeutic purpose.
No
The device is indicated for the "treatment of pseudofolliculitis barbae", not for diagnosis.
No
The device description clearly states it is a "diode laser system" and lists hardware components such as a power unit, chiller, footswitch, and handpiece. This indicates it is a physical medical 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 is for the "treatment of pseudofolliculitis barbae in Skin Types I-VI." This is a therapeutic application, directly treating a condition on the patient's body.
- Device Description: The device is a laser system that delivers light to the patient's skin. This is a physical intervention on the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with patient specimens or any diagnostic purpose.
Therefore, the Palomar Super Long Pulse, SLP™ 1000, diode laser system is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The SLP™ 1000 Diode Laser System is indicated for the treatment of pseudofolliculitis barbae, as well as hair removal, permanent hair reduction, treatment of pigmented and vascular lesions (including facial and leg veins).
The Palomar Super Long Pulse, SLP™ 1000, diode laser system is indicated for the treatment of pseudofolliculitis barbae in Skin Types I-VI.
Product codes
GEX
Device Description
The SLP™ 1000 delivers infrared laser light with a wavelength of 810 nm, a selectable pulse duration of 50 - 1000 ms, and a selectable pulse energy of .5-100 J.
The complete system consists of a power unit, chiller, a footswitch, and a handpiece connected to the laser unit with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch is depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the user interface panel on top of the power unit, which provides an interface to the system computer.
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)
The differences in the specifications of the SLPTM Performance Data: 1000 laser and the predicate device do not result in different performance or raise new questions of safety or efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LightSheer Diode Array Laser, Laserscope Lyra G Surgical Laser System
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
DEC 0 6 2001
Attachment 4
510(K) Summary of Safety and Effectiveness
人口13028
This 510(K) Summary of Safety and Effectiveness for the SLP™ 1000 Diode Array Laser System is submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Palomar Medical Technologies, Inc. |
|---|---|
| Address: | 82 Cambridge St. |
| Burlington, MA 01803 | |
| Contact Person: | Marcy Moore |
| Telephone: | 919-363-2432 |
| Preparation Date: | September 4, 2001 |
| Device Trade Name: | Palomar SLP™ 1000 |
| Common Name: | Super Long Pulse Diode Laser |
| Classification Name: | Laser surgical instrument for use in General and |
| Plastic Surgery and in Dermatology | |
| (see: 21 CFR 878-4810). | |
| Product Code: GEX | |
| Panel: 79 | |
| Legally-Marketed Predicate Device: | LightSheer Diode Array Laser |
| Laserscope Lyra G Surgical Laser System | |
| System Description: | The SLP™ 1000 delivers infrared laser light with a |
| wavelength of 810 nm, a selectable pulse duration | |
| of 50 - 1000 ms, and a selectable pulse energy of | |
| .5-100 J. |
The complete system consists of a power unit,
chiller, a footswitch, and a handpiece connected to
the laser unit with an umbilical. In standard use, the
handpiece is pressed against the patient's skin and a
light pulse is delivered when the footswitch is
depressed. The handpiece tip is water-cooled to |
1
provide active skin cooling. Laser parameters and other system features are controlled from the user interface panel on top of the power unit, which provides an interface to the system computer.
The SLP™ 1000 Diode Laser System is indicated Intended Use of the Device: for the treatment of pseudofolliculitis barbae, as well as hair removal, permanent hair reduction, treatment of pigmented and vascular lesions (including facial and leg veins).
The differences in the specifications of the SLPTM Performance Data: 1000 laser and the predicate device do not result in different performance or raise new questions of safety or efficacy.
Based on the foregoing, the SLP™ 1000 Diode Conclusion: Laser System is substantially equivalent to the legally-marketed claimed predicate device for permanent hair reduction.
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2001
Palomar Medical Products, Inc. c/o Ms. Marcy Moore 131 Kelekent Lane Cary, North Carolina 27511
Re: K013028
Trade Name: Palomar SLP™ 1000 Diode Laser System Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Regulatory Class: II Product Code: GEX Dated: September 6, 2001 Received: September 10, 2001
Dear Ms. Moore:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
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Page 2 & Ms. Marcy Moore
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to organization of substantial equivalence of your device to a legally premits that 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 and II you desire specific advice for your witto diagnostic devices), please contact the Office of additionally 21 OF IC For of 559. Additionally, for questions on the promotion and advertising of Compliance at (301) 59 + 100 + Office of Compliance at (301) 594-4639. Also, please note the your deviced, "Misbranding by reference to premarket notification" (21CFR Part 807.97). I guiation chittion, "Nilocraning on yesponsibilities under the Act may be obtained from the Outcr general informational 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,
Susan Walker, MD
Image /page/3/Picture/5 description: The image shows a handwritten symbol or character. It appears to be a cursive letter, possibly a lowercase 'p' or a similar glyph. The stroke begins with a loop at the top and extends downward with a curved tail.
Celia 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
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INDICATIONS FOR USE STATEMENT
510(K) Number: K013028
Palomar SLP™ 1000 Device Name:
Indications for Use:
The Palomar Super Long Pulse, SLP™ 1000, diode laser system is indicated for the treatment of pseudofolliculitis barbae in Skin Types I-VI.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
Over-the-Counter Use_ OR (per 21 CFR 801.109)
Susan Walker, MD
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number Ka3028
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