PICASSO LASER SYSTEM

K083142 · Amd Lasers, LLC · GEX · Mar 13, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083142
• Device Name: PICASSO LASER SYSTEM
• Applicant: Amd Lasers, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Picasso" is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: · Gingival troughing for crown impressions · Gingivectomy · Gingivoplasty · Gingival incision and excision · Hemostasis and coagulation · Excisional and incisional biopsies · Exposure of unerupted teeth · Fibroma removal · Frenectomy and frenotomy · Implant recovery · Incision and drainage of abscess · Leukoplakia · Operculectomy · Oral papillectomies · Pulpotomy · Pulpotomy as an adjunct to root canal therapy · Reduction of gingival hypertrophy · Soft tissue crown lengthening · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa · Vestibuloplasty Laser periodontal procedures, including: · Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival bleeding index, probe depth, attachment loss and tooth mobility). · Laser soft tissue curettage · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket · Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium Tooth Whitening Indications: · Laser assisted whitening/bleaching of teeth. · Light activation for bleaching materials for teeth whitening.

Device Story

Picasso™ is 810 nm diode laser system; used by dental professionals for oral soft tissue surgery and tooth whitening. Device delivers laser energy to target tissue for incision, excision, vaporization, ablation, or coagulation; also provides light activation for bleaching materials. Operated in dental clinic setting. Healthcare provider directs laser output to specific oral sites to manage soft tissue pathologies or perform cosmetic whitening. Benefits include precise tissue management, hemostasis, and efficient periodontal pocket treatment.

Clinical Evidence

No clinical data presented; bench testing only.

Technological Characteristics

Diode laser; 810 nm wavelength. Used for surgical incision, excision, vaporization, ablation, and coagulation. Form factor is a powered laser instrument. No specific software algorithm or connectivity details provided.

Indications for Use

Indicated for patients requiring oral soft tissue surgery (incision, excision, vaporization, ablation, coagulation), periodontal procedures (sulcular debridement, curettage), or tooth whitening/bleaching. Applicable to general oral soft tissue conditions including gingival hypertrophy, abscesses, ulcers, and lesions.

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

• Biolase® LaserSmile™ (K030539)
• SoftLase™G2, by Zap Lasers™, LLC (K021227)
• Biolase® Twilite™ (K003385)
• SoftLase™ by Zap Lasers™, LLC (K003440)
• Biolase® DioLase Plus™
• Odyssey 2.4G, by Ivoclar Vivadent (K050453)
• Prometey, by Spectrum Lasers (K062071)

Submission Summary (Full Text)

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083142

Page ① of ②

# 510(k) Summary for the Picasso™ by AMD LASERS™, LLC

MAR 1 3 2009

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

# 1. General Information

Submitter:

AMD LASERS™, LLC 7405 Westfield Blvd. Indianapolis, IN 46240

Contact Person:

Kory Schultz 7405 Westfield Blvd. Indianapolis, IN 46240 [phone]

Summary Preparation Date:

October 20, 2008

# 2. Names

Device Name:

Picasso™

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

# 3. Predicate Devices

The Picasso™ is substantially equivalent to:

- Biolase® LaserSmile™ cleared in K030539 .
- SoftLase™G2, by Zap Lasers™, LLC cleared in K021227 .
- Biolase® Twilite™cleared in K003385 .
- SoftLase™ by Zap Lasers™, LLC cleared in K003440 ●
- Biolase* DioLase Plus™ ●
- . Odyssey 2.4G, by Ivoclar Vivadent cleared in K050453
- Prometey, by Spectrum Lasers cleared in K062071 .

# 4. Device Description

The Picasso" is a diode laser with an 810 nm wavelength.

AMD LASERS™, LLC PICASSO™ 510K Submission 7

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083142

ge (2) of (2)

#### Indications for Use 5.

The Picasso" is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:

- · Gingival troughing for crown impressions
- · Gingivectomy
- · Gingivoplasty
- · Gingival incision and excision
- · Hemostasis and coagulation
- · Excisional and incisional biopsies
- · Exposure of unerupted teeth
- · Fibroma removal
- · Frenectomy and frenotomy
- · Implant recovery
- · Incision and drainage of abscess
- · Leukoplakia
- · Operculectomy
- Oral papillectomies
- · Pulpotomy
- · Pulpotomy as an adjunct to root canal therapy
- · Reduction of gingival hypertrophy
- · Soft tissue crown lengthening
- · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- · Vestibuloplasty

### Laser periodontal procedures, including:

· Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical including: gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility).

- Laser soft tissue curettage .
- ◆ Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and ● junctional epithelium

Tooth Whitening Indications:

- Laser assisted whitening/bleaching of teeth. .
- Light activation for bleaching materials for teeth whitening.

#### Performance Data 6.

None presented.

# 7. Manufacturing Facility:

The devices are physically manufactured at the FDA registered: SHANGHAI WONDERFUL OPTO ELECTRICS TECH. CO., LTD 2f (East) Building 10 Lane 561, Nujiang Road (North) Shanghai, CHINA 200333

AMD LASERS™, LLC PICASSO™ 510K Submission 8

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 1 3 2009

AMD Laserss, LLC % O'Connell Regulatory Consultants. Inc. Ms. Maureen O'Connell 5 Timber Lane North Reading, Massachusetts 01864

Re: K083142 Trade/Device Name: Picasso™ . 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 23, 2009 Received: February 24, 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 such 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Maureen O'Connell

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) i 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| <b>Indications for Use</b> |
|----------------------------|
|----------------------------|

| 510(k) Number (if known): | K083142 |
|---------------------------|----------|
| Device Name: | Picasso™ |

## Indications for Use:

The Picasso" is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:

· Gingival troughing for crown impressions

- · Gingivectomy
- · Gingivoplasty
- · Gingival incision and excision
- · Hemostasis and coagulation
- · Excisional and incisional biopsies
- · Exposure of unerupted teeth
- · Fibroma removal
- · Frenectomy and frenotomy
- · Implant recovery
- · Incision and drainage of abscess
- · Leukoplakia
- · Operculectomy
- · Oral papillectomies
- · Pulpotomy
- · Pulpotomy as an adjunct to root canal therapy
- · Reduction of gingival hypertrophy
- · Soft tissue crown lengthening
- · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- · Vestibuloplasty

Laser periodontal procedures, including:

· Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival bleeding index, probe depth, attachment loss and tooth mobility).

- Laser soft tissue curettage ●
- . Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket,
- Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and . junctional epithelium

Tooth Whitening Indications:

- Laser assisted whitening/bleaching of teeth.
- Light activation for bleaching materials for teeth whitening.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over The Counter Use (Part 21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

AMD LASERS", LLC PICASSO" 510K: Submission 6

Neil Reshan Forman

(Division Sign-C Division of General, Restorative, and Neurological Device

510(k) Number K083142