SPECTRA-SP CO2 LASER SYSTEM

K050254 · Max Engineering , Ltd. · GEX · Apr 15, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050254
• Device Name: SPECTRA-SP CO2 LASER SYSTEM
• Applicant: Max Engineering , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Spectra-SP Laser System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery. Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: -Laser skin resurfacing -Treatment of wrinkles, rhytids and furrows -Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas) tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement. Dermatology, Plastic Surgery & General Surgery Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications. Soft Tissue Dental The specific soft tissue dental indications include: Periodontic procedures such as gingivectomy-removal of hyperplasias, gingivoplasty, and incision and excision; Oral surgery such as frenectomy, incisional and excisional biopsy, incision and excision of aphous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, homeostatis, operculectomy, and crown lengthening. Podiatry Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares, and matrixectomy. Otorhinolaryngology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, UPP, rhinophyma, adult and juvenile papillomatosis polyps, rhinophyma and verrucae vulgares. Gynecology Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies) and vulvar and vaginal intraepithelial neoplasia. Neurosurgery Laser incision, excision, ablation and/or vaporization of soft tissue in neurology for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.

Device Story

Spectra-SP Laser System is a surgical CO2 laser console; utilizes DC-excited sealed-off CO2 gas tube to produce 10.6μm coherent infrared beam; features articulated arm delivery system with handpiece and focus lens; includes footswitch and goggles. Operated by clinicians in surgical settings; console contains cooling system, power supply, and control panel with emergency stop. Laser beam directed via handpiece to target soft tissue; dual operation modes (Continuous Wave and Char-Free). Output is focused laser energy for tissue ablation, vaporization, excision, incision, and coagulation. Clinical benefit includes precise soft tissue management across multiple surgical specialties; enables procedures like skin resurfacing, tumor removal, and various excisional surgeries.

Clinical Evidence

No clinical data presented; bench testing only.

Technological Characteristics

CO2 laser system; 10.6μm wavelength; DC-excited sealed-off gas tube; articulated arm delivery; console-based with cooling system and power supply; footswitch-controlled; Class II device.

Indications for Use

Indicated for patients requiring soft tissue ablation, vaporization, excision, incision, or coagulation across dermatology, plastic surgery, podiatry, neurosurgery, gynecology, ENT, arthroscopy, and general surgery specialties.

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

• Lumenis Family of UltraPulse SurgiTouch CO2 Laser Systems (K030147)
• Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories (K022060)
• Lumenis Compact 20C, 30C and 40C CO2 Lasers (K935563 and K963229)
• ESC Medical Systems Luxar LX-20 CO2 Surgical Laser System Family (K991628 and K960475)
• MedArt Uni-Laser 450P CO2 Laser System & Accessories (K991297)

Submission Summary (Full Text)

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# APR 1 5 2005 510(k) Summary of Safety and Effectiveness for the MAX Engineering Ltd. Spectra-SP Laser System

KOSO224

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

# 1. General Information

| Submitter: | MAX Engineering Ltd.<br>421 Ilsan Technotown<br>1141-1 Baeksuk, Ilsan<br>Goyang, Gyunggi,<br>Republic of Korea<br>411-360 | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Maureen O'Connell<br>5 Timber Lane<br>North Reading, MA 01864<br>Telephone: [phone]<br>Fax: [phone] | |
| Summary Preparation Date: | January 26, 2005 | |
| 2. | Names | |
| Device Name: | Spectra-SP Laser System | |
| Classification Name: | Laser Instrument, Surgical Powered<br>Product Code: GEX<br>Panel: Dermatology and Plastic Surgery | |

## 3. Predicate Devices

The Spectra-SP Laser System is substantially equivalent to a combination of the Lumenis Family of UltraPulse SurgiTouch CO2 Laser Systems (K030147), the Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories (K022060), the Lumenis Compact 20C, 30C and 40C CO2 Lasers (K935563 and K963229), the ESC Medical Systems Luxar LX-20 CO2 Surgical Laser System Family (K991628 and K960475), and the MedArt Uni-Laser 450P CO2 Laser System & Accessories (K991297).

## 4. Device Description

The Spectra-SP Laser System consists of a self-contained console, an articulated arm delivery system, a footswitch and a pair of goggles. The Spectra-SP Laser

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produces a beam of coherent infrared (10.6μm) and has dual operation mode. (Continuous Wave & Char-Free)

The main console is the heart of the Spectra-SP Laser and contains the optical system (with DC-Excited Sealed-off Carbon Dioxide GAS Tube), cooling system, system (with DC Enotroller, and power supply. The main console also includes a arm mount, infore over the power on and off, an emergency stop push button that key switch de-energizes the system in emergency situations, and the control panel. There are 4 casters in the console base for moving.

The laser beam exits an articulated arm into a handpiece where it is focused by the final focus lens contained in the handpiece to produce a spot size at the the Imal focal plane. The handpiece components, when inserted in the beam delivery system, change the laser beam characteristics.

## 5. Indications for Use

The Spectra-SP Laser System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery.

# Dermatology & Plastic Surgery

The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

- -Laser skin resurfacing
-Treatment of wrinkles, rhytids and furrows

-Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas) tattoos, telangiectasia, squamous and basal cell ("icoma, spider and epidermal naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.

# Dermatology, Plastic Surgery & General Surgery

Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications.

## Soft Tissue Dental

The specific soft tissue dental indications include: Periodontic procedures such as gingivectomy-removal of hyperplasias, gingivoplasty, and incision and excision;

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Oral surgery such as frenectomy, incisional and excisional biopsy, incision and excision of aphous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, homeostatis, operculectomy, and crown lengthening.

#### Podiatry

Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares, and matrixectomy.

## Otorhinolaryngology (ENT)

Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, UPP, rhinophyma, adult and juvenile papillomatosis polyps, rhinophyma and verrucae vulgares.

#### Gynecology

Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies) and vulvar and vaginal intraepithelial neoplasia.

## Neurosurgery

Laser incision, excision, ablation and/or vaporization of soft tissue in neurology for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.

# 6. Performance Data

None presented.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2005

MAX Engineering Ltd. C/o Ms. Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864

Re: K050254

Trade/Device Name: Spectra-SP Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: 21 CFR 0781787
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 22, 2005 Received: March 23, 2005

Dear Ms. O'Connell:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becter. De device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the stated in the encrosure) to regars) the enactment date of the Medical Device Amendments, or 10 commerce prior to May 20, 1978, the occordance with the provisions of the Federal Food, Drug, devices that have been receire approval of a premarket approval application (PMA). and Costictle rice (710-) mar ac not request to the general controls provisions of the Act. The I ou may, mercrore, market and act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is elassified (bee as regulations as a casting major regulations affecting your device it hay be subject to subject to such additions, Title 21, Parts 800 to 898. In addition, FDA can be Numd in the Cour of Pouchas concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not nean Please be advised that I DA 3 losames or our device complies with other requirements of the Act that ITA has made a determinations administered by other Federal agencies. You must or any rederal statutes and regulations as annoline but not limited to: registration and listing (21 comply with an the 7te 31equirements, n.c. . good manufacturing practice requirements as set CFN Fart 607), adocing (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Maureen O'Connell

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin makemig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial end thus, permits vour premarket notification. The PDA miding of bacteanian of the spermits 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
s and the may be and comments of any and contracted by records the results If you desire specific advice for your device of your ac Also, please note the regulation entitled, the may abtain comact the Office of Complanes at (210) =70 % =1 % =1 807.97). You may obtain "Misbranding by reference to premarkst nothleation (en too Act from the Division of Small other general miormation on your responsion.comer at its toll-free number [phone] or 1 Manufacturers, International and Consumer Fibeliance and Collindustry/support/index.html.

Sincerely yours,

R. A. R.

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known)

| Device Name | Spectra-SP Laser System |
|-------------|-------------------------|
| | KOSO254 |

## Indications for Use:

The Spectra-SP Laser System is indicated for use in surgical applications requiring the The Spectra-St Laser Bystein is incision, and coagulation of soft tissue in medical ablation, vaporization, cacision, metbron, and evel, podiatry, neurosurgery, gynecology, specialles including. dematorogy, padar one 2017, 11:44
otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery.

# Dermatology & Plastic Surgery

Dermatonogy & Trastic Sulfs.
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

-Laser skin resurfacing

-Treatment of wrinkles, rhytids and furrows

- I reathent of wrinkles, in Julas and tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic the reduction, removal, and or a ves, uneven pigmentation/dyschromia, acne scars, elastosis, actime enemals, comrgiomas (including buccal hemangiomas), tattoos, Surgical scars, keloras, nomaligroul cell carcinoma, spider and epidermal naevi, tellanglectasia, squalifous and basar ve, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.

# Dermatology, Plastic Surgerv & General Surgery

Dermatology, I hastic our ce of tissue in dermatology, plastic and general surgery, Laser the Islon and/or exersion of between and for the creation of recipient sites for hair mending the performance of brephersphally atheroma, cysts, abscesses, and all other soft tissue applications.

#### Soft Tissue Dental

Soft I Issue Demal
The specific soft tissue dental indications include: Periodontic procedures such as I he specific soft itsude donal malasias, gingivoplasty, and incision and excision; gingivectorily-removal or rifyperplassas) gings of the start of any incision and excision Oral surgely such as frencotonly, mensional used with antibiotic therapy, excision and of aphous dicers, melsion of infosted in is a submit and crown lengthening.

#### Podiatrv

Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, Laser ablation, vapormation, verrucae vulgares, and matrixectomy.

## Otorhinolaryngology (ENT)

Otoriminoral virgology (21) ================================================================================================================================================== Laser inclision, excision, ablianon and of choanal atresia, leukoplakia of larynx, nasal

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obstruction, UPP, rhinophyma, adult and juvenile papillomatosis polyps, rhinophyma and verrucae vulgares.

#### Gynecology

Caser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the Laser Incision, excision, abidition and of raposted on acuminata, leukoplakia (vulvar treatment of conviour and vaginal intraepithelial neoplasia.

#### Neurosurgery

Neurosurgers
Laser incision, excision, ablation and/or vaporization of soft tissue in neurology for the Laser incision, cxcision, and on and of ' visual to ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' lipomas/large tumors.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Signature

K050254