(155 days)
Not Found
No
The document describes a laser system with user-controlled parameters and a standard operational mode. There is no mention of AI, ML, or any features that suggest automated decision-making or learning from data.
Yes
The device is indicated for medical procedures such as hair removal, photocoagulation of vascular lesions, and removal of pigmented lesions, all of which aim to treat or alleviate a medical condition or effect a change in the body's structure or function.
No
The device description clearly states its intended use is for "photocoagulation (homeostasis) of soft tissue" and lists therapeutic applications such as hair removal and treatment of vascular and pigmented lesions. There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly outlines a physical laser system including a laser unit, chiller, footswitch, and handpiece, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Palomar Super Long Pulse, SLP™ 1000, diode laser system is a therapeutic device that uses laser light to perform surgical procedures on soft tissue, including hair removal, treatment of vascular lesions, and removal of pigmented lesions. It directly interacts with the patient's body.
- Intended Use: The intended use clearly describes surgical procedures performed on the patient, not tests performed on samples from the patient.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SLP™ 2000 Diode Laser System is indicated to remove hair in Dermatology and Plastic Surgery procedures. It is also intended for Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions.
The Palomar Super Long Pulse, SLP™ 1000, diode laser system is indicated for I no rulomar buper and coagulation (homeostasis) of soft tissue. Soft tissue which may be encountered in surgical procedures include skin. subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph suboutined about and glands, and glands, and specifically for the following indications.
Dermatology and Plastic Surgery for: Hair Removal in Skin Types I-VI Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions. Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions Photothermolysis
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The SLP™ 2000 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 corresponding fluence delivered through a 10 mm handpiece tip. The laser pulses are generated at a maximum pulse repetition frequency of 5 Hz by diodes located in the laser unit
The complete system consists of a laser 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 laser 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
soft tissue, skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph suboutined about and glands, and glands.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
The differences in the specifications of the SLP™ 2000 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.)
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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.
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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).
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§ 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
Attachment V
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the SLP™ 2000 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: | November 15, 1999 |
| Device Trade Name: | Palomar SLP™ 2000 |
| 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 |
| Star Medical Technologies, Inc. | |
| K973324 | |
| System Description: | The SLP™ 2000 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 corresponding fluence | |
| delivered through a 10 mm handpiece tip. The laser | |
| pulses are generated at a maximum pulse repetition | |
| frequency of 5 Hz by diodes located in the laser | |
| unit |
1
| The complete system consists of a laser 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 laser unit, which provides an interface to the system computer. | |
|---|---|
| Intended Use of the Device: | The SLP™ 2000 Diode Laser System is indicated to remove hair in Dermatology and Plastic Surgery procedures. It is also intended for Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions. |
| Performance Data: | The differences in the specifications of the SLP™ 2000 laser and the predicate device do not result in different performance or raise new questions of safety or efficacy. |
| Conclusion: | Based on the foregoing, the SLP™ 2000 Diode Array Laser System is substantially equivalent to the legally-marketed claimed predicate device, i.e., the LightSheer™ for hair removal. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
MAY 1 8 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Palomar Medical Technologies, Inc. c/o Ms. Marcy Moore Manager of Clinical Studies 131 Kelekent Lane Gary, North Carolina 27511
Re: K994225
Trade Name: Palomar SLP™ 1000 Regulatory Class: II Product Code: GEX Dated: March 27, 2000 Received: March 29, 2000
Dear Ms. Moore:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Marcy Moore
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
Purnell Page
& & 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
4
INDICATIONS FOR USE STATEMENT
510(K) Number: K994225________________________________________________________________________________________________________________________________________________________
Palomar SLP™ 1000 Device Name:
Indications for Use:
The Palomar Super Long Pulse, SLP™ 1000, diode laser system is indicated for I no rulomar buper and coagulation (homeostasis) of soft tissue. Soft tissue which may be encountered in surgical procedures include skin. subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph suboutined about and glands, and glands, and specifically for the following indications.
Dermatology and Plastic Surgery for: Hair Removal in Skin Types I-VI Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions. Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions Photothermolysis
(Please do not write below this line - Continue on another page if needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
I limal (Division Sign-Off) Division of General Restorative Devices K994228 510(k) Number .
Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use