PALOMAR LC 100 DIODE LASER

K011747 · Palomar Medical Technologies, Inc. · GEX · Aug 30, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K011747
• Device Name: PALOMAR LC 100 DIODE LASER
• Applicant: Palomar Medical Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 30, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

LC100 is a super long pulse diode laser system delivering 810 nm infrared light. System components include a chiller, footswitch, and handpiece with diode bars connected via umbilical. Handpiece features water-cooled tip for active skin cooling. Operated by clinicians in a clinical setting. User interface on top of laser unit controls parameters. Device delivers light pulses (50-1000 ms duration) to target tissue when footswitch is depressed. Clinical application involves pressing handpiece against patient skin to perform hair reduction, lesion treatment, or soft tissue surgery. Output is thermal energy for photothermolysis or coagulation. Benefits include non-invasive or minimally invasive treatment of dermatological conditions and soft tissue management.

Clinical Evidence

Bench testing only.

Technological Characteristics

810 nm diode laser; pulse duration 50-1000 ms; max repetition rate 3.3 Hz; 12x12 mm or 12x6 mm handpiece; water-cooled tip for active skin cooling; system computer with user interface panel.

Indications for Use

Indicated for hair removal, permanent hair reduction, treatment of benign pigmented/vascular lesions (e.g., port wine stains, telangiectasia, angioma, hemangioma, spider nevi, lentigines, nevi, chloasma, café-au-lait), and soft tissue incision/excision, ablation, and coagulation. Applicable to patients skin types I-VI, including tanned skin.

Regulatory Classification

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.

Predicate Devices

• Palomar SLP 1000 Diode Laser (K994225, K010580)
• LightSheer Diode Array Laser (K973324, K974346, K982940, K001746, K003614)

Submission Summary (Full Text)

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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.<br>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 and<br>Plastic Surgery and in Dermatology<br>(see: 21 CFR 878-4810).<br>Product Code: GEX<br>Panel: 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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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 ====================================================================================================================================================== [phone] - 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 [phone] or [phone] 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