LIGHTSHEER

K980420 · Palomar Medical Products, Inc. · GEX · May 4, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980420
• Device Name: LIGHTSHEER
• Applicant: Palomar Medical Products, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LightSheer™ is intended to effect hair removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles. The LightSheer™ is a prescription device (12 CFR 801.109)

Device Story

Long pulse ruby laser for hair removal; delivers energy via two quartz fiber optics; beam exits through chilled handpiece held in contact with skin; targets melanin in hair follicles; operated by clinicians in dermatology/surgery settings; output provides thermal energy for follicle destruction; benefits patient through permanent hair reduction.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Long pulse ruby laser; energy delivery via two quartz fiber optics; chilled handpiece for skin contact; Class II device; GEX product code.

Indications for Use

Indicated for hair removal in patients with skin types I-4 via selective targeting of melanin in hair follicles. Prescription use only.

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

• EpiLaser (K963947)

Submission Summary (Full Text)

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K 9804/20

### APPENDIX F

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### 510(k) SUMMARY

## LightSheer™ Long Pulse Ruby Laser

This 510(k) summary of safety and effectiveness is provided in accordance with the requirements of SMDA 1990 following Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

| Applicant: | Palomar Medical Technologies, Inc. |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 45 Hartwell Avenue<br>Lexington, MA 02173 |
| Contact Person: | Mr. Steven Armstrong<br>Vice President of Quality Assurance<br>and Service<br>President, Palomar Medical<br>Technologies, Inc. |
| Telephone: | 781-676-7300<br>781-676-7330 (Fax) |
| Preparation Date:<br>(of the Summary) | January 30, 1998 |
| Device Trade Name: | LightSheer™ |
| Common Name: | Ruby Laser, long pulse |
| Classification<br>Name | Laser surgical instrument; for use in general and plastic<br>surgery and in dermatology (see: 21 CFR 878.4810).<br>Product Code: GEX<br>Panel: 79 |
| Legally marketed<br>predicate devices | The LightSheer™ is substantially equivalent to the EpiLaserR. |
| Device Description: | LightSheer™ laser is a long pulse ruby laser which delivers its<br>energy to the treatment site via two quartz fiber optics. The<br>beam exits from a chilled hand piece which is held in firm<br>contact with the skin at the treatment site. |

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11

#### MAY 4 1998

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| Intended Use of | The LightSheer™ is intended to effect hair removal of patients<br>with skin types 1 - 4 through selective targeting of melanin in<br>hair follicles.<br>The LightSheer™ is a prescription device (12 CFR 801.109) |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison: | The specifications, performance and intended use of the<br>LightSheer™ are the same or similar as the EpiLaserR described<br>in K963947. The differences between the lasers are not<br>significant in terms of the performance or intended use of the<br>LightSheer™ |
| Performance Data: | None required. |
| SUMMARY: | The similarities of the LightSheer™ and the EpiLaserR<br>demonstrate that the two lasers are substantially equivalent.<br><br>The differences between the LightSheer™ and EpiLaserR do not<br>pose any significant or deleterious effects on either the safety,<br>performance, use, or effectiveness of the LightSheer™.<br><br>The fluences to tissue at the treatment site are the same for the<br>LightSheer™ and the EpiLaserR. |
| Additional:<br>Information | None requested |
| CONCLUSION: | The LightSheer™ long pulse ruby laser is substantially<br>equivalent to the EpiLaserR. |

ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

.

,

arras

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4 1998 MAY

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steven Armstrong Vice President of Quality Assurance and Service Palomar Medical Technologies, Incorporated 45 Hartwell Avenue Lexington, Massachusetts 02173

Re: K980420 Trade Name: LightSheer™ Long Pulse Ruby Laser Requlatory Class: II Product Code: GEX Dated: February 2, 1998 February 3, 1998 Received:

Dear Mr. Armstrong:

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 Existing major be subject to such additional controls. regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬੈ 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 (QS) 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.

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#### Page 2 - Mr. Armstrong

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 your 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Acceffe

a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

510(k) Number: k980420

LightSheer™ Long Pulse Ruby Laser Device Name:

Indications for Use:

The LightSheer™ is intended to effect hair removal of patients with skin types I - 4 through selective targeting of melanin in hair follicles.

Note: The EpiLaser" was limited to prescription use at the time of the substantially equivalent Note: The EpiLaser" was limited to prescription use at the mas of the Books of the LightSheer™ be a limited to prescription use also.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

1985 - 1997

Prescription Use _ (Per 21 CFR 801.109)

OR

Over-The-Counter-Use

(Division Sign-Off)
Division of General Restorative Devices K980420
510(k) Number

010