(86 days)
The LC100 diode laser system is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as a long-term, stable reduction in the number of re-growing hairs after a treatment regime.
The LC100 is also indicated for photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, hemangioma, spider nevi, and other benign vascular lesions; photothermolysis of blood vessels (treatment of facial and leg veins); removal of benign pigmented lesions, including lentigines, nevi, chloasma, and café-au-lait; incision/excision, ablation and coagulation (homeostasis) of soft tissue.
The LC100 is indicated for use in patients with skin types I-VI, including tanned patients.
The LC100 delivers infrared laser light with a wavelength of 810 nm, a selectable pulse duration of 50 - 1000 ms. The corresponding fluence is delivered through a 12x12 or 12x6 mm handpiece tip. The laser pulses are generated at a maximum pulse repetition frequency of 3.3 Hz.
The complete system consists of a, chiller, a footswitch, and a handpiece containing diode bars connected to the power 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-Laser cooled to provide active skin cooling. 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.
The provided document is a 510(k) summary for the Palomar LC100 Diode Array Laser System, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission does not typically include the kind of detailed study data (like acceptance criteria tables, sample sizes for test/training sets, ground truth establishment, MRMC studies, or standalone performance) that would be present in a Clinical Study Report or a more extensive Premarket Approval (PMA) application.
The document primarily focuses on establishing substantial equivalence by comparing the LC100 to predicate devices (Palomar SLP 1000 Diode Laser and LightSheer Diode Array Laser) through a description of its system and intended use. It explicitly states: "The differences in the specifications of the LC100 laser and the predicate device do not result in different performance or raise new questions of safety or efficacy. Based on the foregoing, the LC100 Diode Conclusion: Array Laser System is substantially equivalent to the legally-marketed claimed predicate device."
Therefore, based solely on the provided text, I cannot provide the specific details requested in your prompt because they are not present in this 510(k) summary.
Here's what I can extract or infer based on the nature of a 510(k) submission:
- Acceptance Criteria and Reported Device Performance: Not explicitly stated in a quantitative table. The "acceptance criterion" for a 510(k) is typically substantial equivalence to a predicate device, meaning it performs as safely and effectively as the predicate without raising new questions of safety or efficacy. The "reported device performance" is essentially that it is considered substantially equivalent to the predicate devices for its stated indications for use.
- Study Proving Acceptance Criteria: The "study" is the submission itself, which argues for substantial equivalence by comparing the LC100's specifications and intended use to those of the predicate devices. This is generally a comparative analysis rather than a traditional clinical study with detailed performance metrics.
- Sample Size for Test Set and Data Provenance: Not applicable/not provided. This is not a study that involved a test set in the sense of a clinical trial.
- Number of Experts and Qualifications: Not applicable/not provided. Ground truth establishment with experts is not detailed for this type of submission.
- Adjudication Method: Not applicable/not provided.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable/not provided. These are complex studies not typically required or included in a 510(k) for a laser system.
- Standalone Performance: Not applicable/not provided as a distinct study. The comparison is against predicate devices.
- Type of Ground Truth Used: Not applicable/not provided as this is not a diagnostic device requiring external validation of its output against a 'ground truth.'
- Sample Size for Training Set: Not applicable/not provided. This device is not an AI/ML algorithm that would have a training set.
- How Ground Truth for Training Set was Established: Not applicable/not provided.
In summary, the provided document is a regulatory submission for substantial equivalence, not a detailed clinical performance study. The information requested regarding explicit acceptance criteria, detailed study design, sample sizes, and ground truth establishment is not typically found in this type of 510(k) summary.
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KO11747
Attachment 5
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the LC100 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: | June 1, 2001 |
| Device Trade Name: | Palomar LC100 |
| Common Name: | Super Long Pulse Diode Laser |
| Classification Name: | Laser surgical instrument for use in General andPlastic Surgery and in Dermatology(see: 21 CFR 878-4810).Product Code: GEXPanel: 79 |
| Legally-Marketed Predicate Device: |
Palomar SLP 1000 Diode Laser Palomar Medical Technologies, Inc. K994225; K010580
LightSheer Diode Array Laser Star Medical Technologies, Inc. K973324, K974346, K982940, K001746, K003614
System Description:
The LC100 delivers infrared laser light with a wavelength of 810 nm, a selectable pulse duration of 50 - 1000 ms. The corresponding fluence is delivered through a 12x12 or 12x6 mm handpiece
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tip. The laser pulses are generated at a maximum pulse repetition frequency of 3.3 Hz.
The complete system consists of a, chiller, a footswitch, and a handpiece containing diode bars connected to the power 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-Laser cooled to provide active skin cooling. 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.
the legally-marketed claimed predicate device, i.e., the SLP1000™ and LightSheer™ diode lasers.
Intended Use of the Device: The LC100 Diode Laser System is indicated for haire removal, permanent hair reduction, treatment of pigmented and vascular lesions, including leg incision/excision, ablation and veins, and coagulation of soft tissue (for patients with skin types I-VI, including tanned skin). The differences in the specifications of the LC100 Performance Data: laser and the predicate device do not result in different performance or raise new questions of safety or efficacy. Based on the foregoing, the LC100 Diode Conclusion: Array Laser System is substantially equivalent to
1 Q
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2001
Palomar Medical Technologies, Inc. c/o Ms. Marcy Moore 131 Kelekent Lane Cary, North Carolina 27511
Re: K011747
Trade/Device Name: Palomar LC100 Regulation Number: 878.4810 Regulatory Class: II Product Code: GEX Dated: May 31, 2001 Received: June 5, 2001
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 atoo 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). You may, therefore, market the device, subject to the general controls Contistions of the Act. The general controls provisions of the Act include requirements for annual provisions 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 (1 remance rippt of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspootions, the Pood and on 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.
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Page 2 - Ms. Marcy Moore
This letter will allow you to begin marketing your device as described in your 510(k) premarket This lotter will and in your ding of substantial equivalence of your device to a legally marketed notification. The I Dr I manage sification 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 rr you desire specific dain vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 101 ====================================================================================================================================================== (201) 594-1639 - 1057 - 1051 - 1031) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monmation on your responsibility on the 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,
Sus-Wall-ton M.D.
Fon
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: K011747
Device Name: Palomar LC100
Indications for Use:
The LC100 diode laser system is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as a long-term, stable reduction in the number of re-growing hairs after a treatment regime.
The LC100 is also indicated for photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, hemangioma, spider nevi, and other benign vascular lesions; photothermolysis of blood vessels (treatment of facial and leg veins); removal of benign pigmented lesions, including lentigines, nevi, chloasma, and café-au-lait; incision/excision, ablation and coagulation (homeostasis) of soft tissue.
The LC100 is indicated for use in patients with skin types I-VI, including tanned patients.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
signature
(Division Sign-Off) (Division Sigir Oxx)
Division of General, Restorative Division of Sgical Devices
510(k) Number K011747
§ 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.