LORAD LT-100 LASER TREATMENT SYSTEM

K992597 · Focus Medical, LLC · GEX · Apr 24, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K992597
• Device Name: LORAD LT-100 LASER TREATMENT SYSTEM
• Applicant: Focus Medical, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 24, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lorad LT-100 Laser Treatment System is intended for use: alone or in combination with an adjuvant lotion for the removal or lightening of unwanted facial or body hair. One or two treatments may be required for lightening or removing unwanted hair without the adjuvant lotion; in combination with the adjuvant lotion for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery; dermal pigmented lesions (dermal melanocytosis); and for tattoo removal (dark and blue inks). The adjuvant lotion is a suspension of carbon powder in a base of Light Mineral Oil, NF. The Lorad LT-100 Laser Treatment System will be limited to use by licensed professionals (as provided in 21 CFR 801.109).

Device Story

The LT-100 is a Q-switched Nd:YAG laser system emitting energy at 1064 nm. It is used by licensed professionals in clinical settings for hair removal/lightening, skin resurfacing, treatment of dermal pigmented lesions, and tattoo removal. For certain applications, the device is used in combination with an adjuvant lotion consisting of carbon powder in a light mineral oil base. The laser energy interacts with the target tissue or the adjuvant lotion to achieve the desired aesthetic or dermatological effect. The device is operated by a physician or licensed professional who directs the laser output to the treatment area to affect clinical outcomes such as hair reduction or skin ablation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Q-switched Nd:YAG laser system; 1064 nm wavelength; utilizes adjuvant carbon powder lotion for specific applications; intended for professional use; device classification 21 CFR 878.4810.

Indications for Use

Indicated for individuals requiring removal or lightening of unwanted facial or body hair, skin resurfacing, treatment of dermal pigmented lesions (dermal melanocytosis), or removal of dark and blue ink tattoos. Limited to use by licensed professionals.

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

• ThermoLase SoftLight
• Medlite™ Q-Switched Nd:YAG Laser
• Medlite™ IV Q-Switched Nd:YAG Laser

Submission Summary (Full Text)

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# 长992597

# APPENDIX D

# SUMMARY OF SAFETY AND EFFECTIVENESS

### LT-100 Q-SWITCHED ND: YAG LASER TREATMENT SYSTEM

This 510(k) summary of safety and effectiveness for the LT-100 Laser Treatment System was prepared using guidance from the Office of Device Evaluation and is intended to comply with the requirements of SMDA 1990.

| Applicant: | Focus Medical LLC |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 19 Silver Spring Park<br>Ridgefield, CT 06810 |
| Contact Person: | Mr. John Lee<br>President |
| Telephone: | 203-438-1120<br>203-438-3169 (Fax) |
| Preparation Date: | April 2000 |
| Device Trade Name: | LT-100 Laser Treatment System |
| Common Name: | Neodymium: Yttrium, Aluminum; Garnet (Nd:YAG) Laser System;<br>Q-Switched Nd:YAG Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and<br>in dermatology (see: 21 CFR 878.4810).<br>Product Code: GEX<br>Panel 79 |
| Predicate Devices: | ThermoLase SoftLight, Continuum Biomedical, Inc., Medlite™ and<br>Medlite™ IV Q-Switched Nd:YAG Lasers. |
| Device Description: | The LT-100 Laser Treatment System is a Q-Switched Nd:YAG which<br>emits its energy at 1064 nm. |

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The LT-100 Laser Treatment System is intended for use:

alone or in combination with an adjuvant lotion for the removal or lightening of unwanted facial or body hair. One or two treatments may be required for lightening or removing unwanted hair without the adjuvant lotion;

in combination with an adjuvant lotion for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery;

dermal pigmented lesions (dermal melanocytosis); and

for tattoo removal (dark and blue inks).

The adjuvant lotion is a suspension of carbon powder in a base of Light Mineral Oil, NF.

The LT-100 will be limited to use by licensed professionals (as provided in 21 CFR 801.109).

None. The specifications and intended uses of the LT-100 Laser Treatment Performance Data: System are the same as or very similar (substantially equivalent) to those of the claimed predicate devices. There are no significant differences between the devices under conditions of intended use.

Because of this, performance data were not required.

Conclusion: The LT-100 Laser Treatment Laser System is substantially equivalent to legally marketed predicate devices, i.e., the ThermoLase SoftLight and the Continuum Biomedical, Inc., Medlite™ and Medlite™ IV Q-Switched Nd: YAG Lasers.

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Public Health Service

APR 2 4 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Lee President Focus Medical, LLC 39 Silver Spring Park Ridgefield, Connecticut 06877

Re: K992597

> Trade Name: LT-100 Laser Treatment System Regulatory Class: II Product Code: GEX Dated: February 15, 2000 Received: February 17, 2000

Dear Mr. Lee:

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 (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. John Lee

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,

vonne R. Lochner.

1/\ Celia 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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#### APPENDIX B Rev. 4/2000

# INDICATIONS FOR USE STATEMENT

K992597 510(K) Number (if known): __

Device Name: Lorad LT-100 Laser Treatment System --------

Indications For Use Statement:

The Lorad LT-100 Laser Treatment System is intended for use:

alone or in combination with an adjuvant lotion for the removal or lightening of unwanted facial or body hair. One or two treatments may be required for lightening or removing unwanted hair without the adjuvant lotion;

in combination with the adjuvant lotion for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery;

dermal pigmented lesions (dermal melanocytosis); and

for tattoo removal (dark and blue inks).

The adjuvant lotion is a suspension of carbon powder in a base of Light Mineral Oil, NF

The Lorad LT-100 Laser Treatment System will be limited to use by licensed professionals (as provided in 21 CFR 801.109).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use N (Per 21 CFR 801. 109) OR

Over-The-Counter Use

e R. Kocher.

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992597