THE FRIENDLYLIGHT ND: YAG LASERS

K033251 · Innotech USA, Inc. · GEX · Mar 2, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033251
• Device Name: THE FRIENDLYLIGHT ND: YAG LASERS
• Applicant: Innotech USA, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The FriendlyLight® Nd: YAG lasers are intended to be used in the medical specialties of general and plastic surgery, dermatology, endoscopic general surgery, gastroentermology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculaplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. Dermatology: The FriendlyLight® Nd: YAG Laser systems are intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The FriendlyLight® Nd: YAG lasers are also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles. The FriendlyLight® Nd: YAG lasers are also indicated for the removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The FriendlyLight® Nd:YAG lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The FriendlyLight® Nd: YAG lasers are indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin. Surgical Application: The lasers are indicated for the incision/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laproscopy gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT) neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/ thoracic surgery, gynecology (e.g. menorrhagia) and urology.

Device Story

FriendlyLight® Nd:YAG Laser system; consists of power supply, air-cooling system, foot switch, and handpiece. Device delivers laser energy to target tissue via handpiece; parameters controlled via front display panel. Used by clinicians in surgical and aesthetic settings. Laser energy targets melanin in hair follicles for hair reduction; targets vascularity in lesions/scars for coagulation/hemostasis; performs soft tissue incision/excision/ablation. Benefits include treatment of benign lesions, hair removal, and surgical soft tissue management. Clinician observes treatment area directly; output affects clinical decision-making regarding lesion management and surgical intervention.

Clinical Evidence

Bench testing only. Device tested according to international standards equivalent to IEC 601. No clinical data provided.

Technological Characteristics

Nd:YAG laser source; air-cooling system; power supply unit with display panel; foot/hand switch activation. Operates as a surgical laser instrument. No specific material standards or software architecture details provided.

Indications for Use

Indicated for patients of all skin types (Fitzpatrick I-IV), including tanned skin, requiring surgical or aesthetic procedures in general/plastic surgery, dermatology, ENT, gastroenterology, gynecology, neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery, and urology. Specific applications include coagulation/hemostasis of vascular/pigmented lesions, treatment of benign cutaneous lesions, hair reduction, PFB treatment, wrinkle reduction, and soft tissue incision/excision/ablation.

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

• Altus Medical CoolGlide® Aesthetic Lasers (k022226)
• Palomar Q-YAG Nd:YAG Laser System (k023967)
• Candela Long Pulse Nd:YAG Laser (k010104)
• GentleYAG Laser System (k022951)
• Continuum Medical Laser System (k970808)
• Continuum Medical Laser System (k014234)
• CoolTouch Varia Nd:YAG Surgical Laser System (k010316)
• CoolTouch Varia-II Nd:YAG Surgical Laser System (k010316)
• Cosmos Medical Athos Long Pulse Nd: YAG laser (k001704)
• Laserscope Lyra Surgical Laser System (k990903)
• Laserscope Lyra Surgical Laser System (k020021)
• Sciton Image Laser System (k012552)

Submission Summary (Full Text)

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MAR - 2 2004

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# 510(k) Summary The FriendlyLight® Nd:YAG Lasers

Submitted by:

Innotech USA, Inc. FriendlyLight® Aesthetic Lasers Division 777 Old Saw Mill River Road, Suite 205 Tarrytown, NY 10591

October 2, 2003

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

| Contact Person: | Howard M. Holstein, Esq., Partner |
|-----------------|-----------------------------------|
| | Hogan & Hartson L.L.P. |
| | Columbia Square |
| | 555 Thirteenth Street, NW |
| | Washington, DC 20004-1109 |
| | Phone: [phone] |
| | Telefax: [phone] |
| | E-mail: [e-mail] |

#### Device Name and Classification: 2.

| Trade Name: | The FriendlyLight® Nd:YAG Lasers |
|-----------------------|-----------------------------------------------|
| Classification Name: | Laser instrument, surgical, powered |
| Common Name: | Neodymium doped Yttrium-Aluminum-Garnet Laser |
| Classification Panel: | General and Plastic Surgery: Panel 79 |
| CFR Section: | 21 CFR §878.4810 |
| Device Class: | Class II |

#### 3. Substantial Equivalence:

The FriendlyLight® Nd:YAG Lasers are substantially equivalent to the current, legally marketed Family of Altus Medical CoolGlide® Aesthetic Lasers (k022226), Palomar Q-YAG Nd:YAG Laser System (k023967), Candela Long Pulse Nd:YAG Laser (k010104) and GentleYAG Laser System (k022951), Continuum Medical Laser System (k970808 and k014234), CoolTouch "Varia" and "Varia-II" Nd:YAG Surgical Laser Systems (k010316),

510(k) for the FriendlyLight® Nd: YAG Lasers

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## 2/3 K033251

Cosmos Medical Athos Long Pulse Nd: YAG laser (k001704), Laserscope's Lyra Surgical Cosmos Mccuration Long Long Lary AG configuration) (k990903 and k020021), Sciton Image Laser System & recessoriese (k012552). The FriendlyLight® Nd: YAG Lasers have the same intended use and general and specific indications as the predicated CoolGlide® devices. Same intendou and geimilar principles of operation and technological characteristics. The These devices have very erf early not raise any new questions of safety and effectiveness. Thuror technological chat FriendlyLight® Nd: YAG Lasers are as safe and effective as the predicated devices.

## Device Description: 4.

The FriendlyLight® Nd:YAG Laser consists of a power supply unit, an air-cooling system, a foot The I hollying.in - 1 to - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Switch, and the hard prove are, the hand piece is held against the treatment area and the light an unfollow cord. In bather the foot switch and/or hand switch is depressed. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.

## Intended Use/Indications for Use: 5.

The FriendlyLight® Nd: YAG Lasers are intended to be used in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroentermology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculaplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.

## Dermatology:

Dematongs):
The FriendlyLight® Nd: YAG Laser systems are intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civalte; and tenate of benign cutaneous lesions, such as warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, (see oped), in tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.

Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

The FriendlyLight® Nd: YAG Lasers are also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.

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The FriendlyLight® Nd: YAG Lasers are also indicated for the removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbac (PFB).

The FriendlyLight® Nd. Y AG Lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The FriendlyLight® Nd: YAG Lasers are indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin.

## Surgical Application:

The lasers are indicated for the incision/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laproscopy gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT) neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/ thoracic surgery, gynecology (e.g. menorrhagia) and urology.

### Performance Data: 6.

The FriendlyLight® Nd: YAG Lasers have been thoroughly tested according to international standards equivalent to the standard IEC 601. Results from the testing indicate that the device is as safe and effective as the predicate devices.

### 7. Conclusion:

The FriendlyLight® Nd: YAG Lasers are substantially equivalent to the current legally marketed Family of Altus Medical CoolGlide® Aesthetic Lasers (k022226), Palomar Q-YAG Nd:YAG Laser System (k023967), Candela Long Pulse Nd: YAG (k010104) and GentleYAG Laser System (k022951), Continuum Medical Laser System (k970808 and k014234), CoolTouch "Varia" and "Varia-II" Nd:YAG Surgical Laser Systems (k010316), Cosmos Medical Athos Long Pulse Nd: YAG laser (k001704), Laserscope's Lyra Surgical Laser System & Accessories (Nd:YAG configuration) (k990903 and k020021), Sciton Image Hair Removal Nd: YAG Laser (k012552).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 2 2004

Innotech USA, Inc. c/o Howard M. Holstein, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, D.C. 20004-1109

Re: K033251

Trade/Device Name: FriendlyLight Nd:YAG Lasers Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 5, 2004 Received: February 5, 2004

Dear Mr. Holstein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sated in the enekessary to the enactment date of the Medical Device Amendments, or to conninered prof to Price 20, 1978, in accordance with the provisions of the Federal Food, Drug, devices that have boon require approval of a premarket approval application (PMA). and cosmetic rice (110) min the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains 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 (sec above) into either class II (Spccial Controls) or class III (PMA), it If your device is elassified (600 a00 vyrols. Existing major regulations affecting your device can hiay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that I'DA's issuance of a substantial equivalence determination does not mean i Toase be advised that I Dr o medales at your device complies with other requirements of the Act that I DA has Intatutes and regulations administered by other Federal agencies. You must of any I callars statutes and regarments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fat 6077, adoning (21 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic form in the qualis) Bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Howard M. Holstein, Esq.

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to begin inding of substantial equivalence of your device to a legally premitset notification. The PPA mailigs of cation 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), please If you desire specific acreoliance at [phone]. Also, please note the regulation entitled, Colider the Office of Over to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincercly yours,

Miriam C. Provost

(a 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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# INNOTECH USA, INC.

## INDICATIONS FOR USE STATEMENT

K 033251 New Submission_ 510(k) Number:

FriendlyLight® Nd:YAG Lasers Device Name: _______________

Indications for Use:

The FriendlyLight® Nd: YAG lasers are intended to be used in the medical specialties of general and plastic surgery, dermatology, endoscopic general surgery, gastroentermology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculaplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.

Dermatology:

The FriendlyLight® Nd: YAG Laser systems are intended for the coagulation and hemostasis of henign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutancous lesions, such as warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE) miriam C. Thorost (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number_K 6 3.3 257 Prescription Use し (per 21 CFR 801.109)

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INNOTECH USA, Inc. Indication for Use Statement Page 2

Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lessons that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

The FriendlyLight® Nd: YAG lasers are also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.

The FriendlyLight® Nd: YAG lasers are also indicated for the removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB).

The FriendlyLight® Nd:YAG lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The FriendlyLight® Nd: YAG lasers are indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin.

## Surgical Application:

The lasers are indicated for the incision/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laproscopy gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT) neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/ thoracic surgery, gynecology (e.g. menorrhagia) and urology.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)
*Miriam C. Provost*
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

| 510(k) Number | K033251 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(per 21 CFR 801.109) | |
|------------------------------------------|----------------------|
| | Over-the-Counter Use |