SPECTRA SP II, SPECTRA DENTA II

K091320 · Lutronic Corporation · GEX · Aug 19, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091320
• Device Name: SPECTRA SP II, SPECTRA DENTA II
• Applicant: Lutronic Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Spectra DENTA II Laser System is indicated for use in soft tissue dental indications including periodontic procedures such as, but not limited to, removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), vaporization, gingivectomy-removal of hyperplasias, gingivoplasty, papillectomy, vestibuloplasty, fibroma (nonmalignant tumor, mucosa, tongue), epulis, incision and excision, removal of soft tissue, cysts, and tumors, and laser assisted new attachment procedure (cementummediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium); Oral surgery such as frenectomy, frenum release, drainage (abscess), flap surgery, incisional and excisional biopsy, incision and excision of aphthous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, oral cavity tumors and hemangiomas, salivary gland pathologies, preprosthetic gum preparation, leukoplakia; partial glossectomy, periodontal gum resection, homeostasis, operculectomy, and crown lengthening. The Spectra SP II 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.

Device Story

Spectra DENTA II and Spectra SP II are CO2 laser systems (10.6um) for soft tissue surgery. System comprises console, articulated arm, footswitch, goggles, and interchangeable handpieces. Console houses DC-excited sealed-off CO2 tube, cooling system, power supply, and microcontroller. Operation modes include Continuous Wave, Char-Free, and Super Pulse. Used in clinical settings by physicians/dentists. Laser beam exits articulated arm into handpiece; final focus lens determines spot size at treatment plane. Output is infrared light beam for tissue ablation, vaporization, excision, incision, or coagulation. Clinical benefit: precise soft tissue management across multiple surgical specialties.

Clinical Evidence

No clinical data presented; bench testing only.

Technological Characteristics

CO2 laser (10.6um); DC-excited sealed-off gas tube; articulated arm delivery; Continuous Wave, Char-Free, and Super Pulse modes; console-based with microcontroller; interchangeable handpieces; Class II device.

Indications for Use

Indicated for soft tissue surgical procedures (ablation, vaporization, excision, incision, coagulation) in dental, dermatological, plastic, podiatric, neurosurgical, gynecological, ENT, and general surgical specialties. Patient population includes adults and children requiring soft tissue management for conditions ranging from benign/malignant lesions and tumors to periodontal disease, skin resurfacing, and various anatomical obstructions/pathologies.

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

• Lutronic Corporation Spectra SP Laser System (K050254)
• Lumenis Family of UltraPulse SurgiTouch CO2 Laser Systems (K030147)
• Lumenis Compact 30C CO2 Lasers (K935563)
• Lumenis Compact 30C CO2 Lasers (K963229)
• MedArt Uni-Laser 450P CQ2 Laser System & Accessories (K991297)
• OpusDent Ltd. Opus Duo EC (K021508)
• Cynosure Smart US 20 D / UltraSpeed, and Smart Clinic Laser (K081181)

Submission Summary (Full Text)

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91320 page (1) of (3)

# 510(k) Summary for the Lutronic Corporation Spectra DENTA II/Spectra SP II Laser Systems

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

### 1. General Information

# AUG 1 9 2009

| Submitter: | Lutronic Corporation<br>#403-2,3,4, Ilsan Technotown<br>1141-1 Baeksok-Dong, Ilsan-Gu<br>Goyang-Si, Gyeonggi-Do, 410-722<br>Republic of Korea |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Telephone: [phone] Fax: [phone]

Summary Preparation Date:

2. Names

Device Name:

Contact Person:

Classification Name:

Spectra DENTA II Laser System Spectra SP II Laser System

April 29, 2009

Laser Instrument, Surgical, Powered Product Code: GEX Panel: General & Plastic Surgery

### 3. Predicate Devices

The Spectra DENTA II and Spectra SP II Laser Systems are substantially equivalent to a combination of the Lutronic Corporation Spectra SP Laser System (K050254), the Lumenis Family of UltraPulse SurgiTouch CO2 Laser Systems (K030147), the Lumenis Compact 30C CO2 Lasers (K935563 and K963229), the MedArt Uni-Laser 450P CQ2 Laser System & Accessories (K991297), the OpusDent Ltd. Opus Duo EC (K021508) and the Cynosure Smart US 20 D / UltraSpeed, and Smart Clinic Laser (K081181).

### 4. Device Description

The Spectra DENTA II and Spectra SP II Laser Systems are identical CO2 laser systems supplied with different handpieces depending upon the indications for use. They consist of a self-contained console, an articulated arm delivery system, a footswitch and a pair of goggles. The Spectra DENTA II and Spectra SP II Laser Systems produce a beam of coherent infrared (10.6um) light and have Continuous Wave, Char-Free and Super Pulse operation modes.

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K091320 Page 0 of 3

The main console is the heart of the Spectra DENTA II and Spectra SP II Laser Systems and contain the optical system (with DC-Excited Sealed-off Carbon Dioxide gas tube), cooling system, arm mount, micro-controller, and power supply. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the control panel. There are 4 casters in the console base for moving the system.

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 treatment focal plane. The handpiece components, when inserted in the beam delivery system, change the laser beam characteristics. Different handpieces are provided with the Spectra DENTA II and the Spectra SP II depending upon the desired indications for use.

### 5. Indications for Use

The Spectra DENTA II Laser System is indicated for use in soft tissue dental indications including periodontic procedures such as, but not limited to, removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), vaporization, gingivectomy-removal of hyperplasias, gingivoplasty, papillectomy, vestibuloplasty, fibroma (nonmalignant tumor, mucosa, tongue), epulis, incision and excision, removal of soft tissue, cysts, and tumors, and laser assisted new attachment procedure (cementummediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium); Oral surgery such as frenectomy, frenum release, drainage (abscess), flap surgery, incisional and excisional biopsy, incision and excision of aphthous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, oral cavity tumors and hemangiomas, salivary gland pathologies, preprosthetic gum preparation, leukoplakia; partial glossectomy, periodontal gum resection, homeostasis, operculectomy, and crown lengthening.

The Spectra SP II 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 Surgerv

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

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K091320 page 3 of 3

hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications.

#### 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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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Lutronic Corporation % O'Connell Regulatory Consultants Ms. Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864

AUG 1 9 2009

Re: K091320

Trade/Device Name: Spectra DENTRA II Laser System Spectra SP II Laser System

Regulation Number: 21 CFR 878.4810

Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Regulatory Class: Class II ---Product Code: GEX Dated: July 3, 2009 Received: July 6, 2009

Dear Ms. O'Connell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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# Page 2 - Ms. Maureen O'Connell

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free momber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

For
Mark N. Melkerson
Dep Dir

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| | Indications for Use |
|---------------------------|---------------------|
| 510(k) Number (if known): | K091320 |
| | |

Device Name: Spectra DENTA II Laser System

### Indications for Use:

The Spectra DENTA II Laser System is indicated for use in soft tissue dental indications including periodontic procedures such as, but not limited to, removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), waporization, gingivectomy-removal of hyperplasias, gingivoplasty, papillectomy, vestibuloplasty, fibroma (nonmalignant trimor, mucosa, tongue), epulis, incision and excision, removal of soft tissue, cysts, and tumors, and laser assisted new attachment procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium); Oral surgery such as frenectomy, frenum release, drainage (abscess), flap surgery, incisional and excisional biopsy, incision and excision of aphthous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, oral cavity turnors and hemangiomas, saliyeny gland pathologies, preprosthetic gum preparation, leukoplakia; partial glossectomy, periodontal gum resection, homeostasis, operculectomy, and crown lengthening.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109) 96)

OR

Page 1 of 3

Over The Counter Use (Optional Format 1-2-

forman
(Division Sign-Off)
Division of Surgical, Orthopedic,

and Restorative Devices

510(k) Number K091320 17

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| Indications for Use | |
|---------------------------|----------------------------|
| 510(k) Number (if known): | KU9132J |
| Device Name: | Spectra SP II Laser System |

Indications for Use:

The Spectra SP II 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.

#### Podiatry

510(k) Number

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| X Prescription Use (Per 21 CFR 801.109) | |
|-----------------------------------------|--|
|-----------------------------------------|--|

*Nul Re Ogle for mxm*

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

OR

| Over The Counter Use (Optional Format 1-2-) | |
|---------------------------------------------|--|
|---------------------------------------------|--|

Page 2 of 3

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091320

### 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109) તેર)

OR

Over The Counter Use (Optional Format 1-2-

96)

Nikola Tesla

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 3 of 3

510(k) Number K091320 19