Picasso Plus, Picasso Lite Plus

K152939 · Amd Group, LLC · GEX · Nov 25, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K152939
• Device Name: Picasso Plus, Picasso Lite Plus
• Applicant: Amd Group, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 25, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Picasso Plus / Picasso Lite Plus is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: Gingival troughing for crown impression; 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; and Vestibuloplasty. Laser Periodontal Procedures, including: Sulcular debridement (curettage, removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility); Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium; and Picasso assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium). Teeth Whitening Indications (Picasso Plus Only): Laser assisted whitening of teeth and Light activation for whitening materials for teeth whitening.

Device Story

Picasso Plus and Picasso Lite Plus are semiconductor diode lasers for oral soft tissue surgery and teeth whitening. Device uses semiconductor diodes as energy source; energy delivered via flexible fiber optic cable to handpiece; handpiece utilizes disposable tips or strippable fiber. Operated by clinician via wireless footswitch. Laser energy performs incision, excision, vaporization, ablation, and coagulation of soft tissues; also used for periodontal debridement and teeth whitening. Output is laser light; clinician directs energy to target tissue to achieve surgical or therapeutic effect. Benefits include precise tissue management and periodontal pocket treatment. Used in dental clinic settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Semiconductor diode laser; flexible fiber delivery system; wireless footswitch control; Class II device. Designed to comply with federal and international safety/performance standards.

Indications for Use

Indicated for oral soft tissue surgical, non-surgical, and periodontal procedures in patients requiring incision, excision, vaporization, ablation, or coagulation. Picasso Plus also indicated for laser-assisted teeth whitening.

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

• Picasso (K083142)
• Picasso and Picasso Lite (K102359)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle, there is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

November 25, 2015

Amd Group LLC Scott Edwards Director, Quality Assurance And Regulatory Affairs 7405 Westfield Blvd. Indianapolis, Indiana 46240

Re: K152939

Trade/Device Name: Picasso Plus, Picasso Lite Plus 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: October 2, 2015 Received: October 5, 2015

Dear Scott Edwards:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Joshua C. Nipper -S

For

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration<br><b>Indications for Use</b> |
|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number ( <i>if known</i> ) | K152939 |
| Device Name | Picasso Plus and Picasso Lite Plus |
| Indications for Use (Describe) | The Picasso Plus / Picasso Lite Plus is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: Gingival troughing for crown impression; 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; and Vestibuloplasty.<br>Laser Periodontal Procedures, including: Sulcular debridement (curettage, removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility); Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium; and Picasso assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).<br>Teeth Whitening Indications (Picasso Plus Only): Laser assisted whitening of teeth and Light activation for whitening materials for teeth whitening. |
| Type of Use (Select one or both, as applicable) | |
| <div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> | <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> |

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## 510(k) Summary

As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR § 807.92, 510(k) summary is provided.

### DATE: November 23, 2015

#### SUBMITTER -

AMD GROUP LLC dba AMD LASERS 7405 Westfield Blvd Indianapolis, IN 46240 USA

Phone: [phone] Fax: [phone]

Contact Person: Scott A. Edwards Date Prepared: November 9, 2015

### II. OFFICIAL CORRESPONDENCE/CONTACT PERSON

Scott A. Edwards Director of QA/RA AMD GROUP LLC Phone: [phone] x900 e-mail: [e-mail]

### III. 510(K) PREPARER

Scott A. Edwards Director of QA/RA AMD GROUP LLC Phone: [phone] x900 e-mail: [e-mail]

### IV. DEVICE

Brand Name of Device: Picasso Plus and Picasso Lite Plus Common or Usual Name: Laser Instrument, Surgical, Powered Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology (21CFR 878.4810) Regulatory Class: II Product Code: GEX 510(k) Number: K152939

> Confidential and Proprietary Copyright © 2015 AMD GROUP LLC

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## V. PREDICATE DEVICE

Device Trade Name: Picasso and Picasso Lite Device Company: AMD LASERS 510(k) Numbers: K083142 andK102359

## VI. DEVICE DESCRIPTION

The Picasso line of soft tissue dental lasers is designed for a wide variety of oral soft tissue surgical, non-surgical, and teeth whitening procedures. Picasso Plus and Picasso Lite Plus lasers employ semiconductor diodes as a laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The laser delivery used may be in the form of strippable fiber or a multi-tip handpiece that is used in conjunction with disposable tips. The device is activated by means of a wireless footswitch.

#### INDICATIONS FOR USE VII.

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

- 0 Gingival troughing for crown impression
- Gingivectomy
- Gingivoplasty O
- Gingival incision and excision 0
- Hemostasis and coagulation 0
- Excisional and incisional biopsies 0
- 0 Exposure of unerupted teeth
- Fibroma removal 0
- 0 Frenectomy and frenotomy
- O Implant recovery
- O Incision and drainage of abscess
- Leukoplakia 0
- Operculectomy 0
- Oral papillectomies 0
- Pulpotomy O
- O Pulpotomy as an adjunct to root canal therapy
- Reduction of gingival hypertrophy 0
- Soft tissue crown lengthening 0
- Treatment of canker sores, herpetic and aphthous ulcers of the oral 0 mucosa
- Vestibuloplasty

Confidential and Proprietary Copyright © 2015 AMD GROUP LLC

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Laser Periodontal Procedures, including:

- Sulcular debridement (curettage, removal of diseased, infected, inflamed 0 and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
- Removal of highly inflamed edematous tissue affected by bacteria O penetration of the pocket lining and junctional epithelium
- 0 Picasso assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).

Teeth Whitening Indications (Picasso Plus Only):

- Laser assisted whitening of teeth 0
- Light activation for whitening materials for teeth whitening 0

#### VIII. SUBSTANTIAL EQUIVALENCE

K083142: Picasso

K102359: Picasso and Picasso Lite

### IX. PERFORMANCE DATA DEMONSTRATING SUBSTANTIAL EQUIVALENCE

The Picasso Plus and Picasso Lite Plus devices have the same intended use and operating principles, with similar design features, and functional and performance characteristics as the previously-cleared devices. The devices are designed to comply with relevant federal and international safety and performance standards. Conformance to these standards, coupled with no changes in the Indications for Use and no change in the fundamental scientific technology demonstrates substantial equivalence to the predicate devices.

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## X. SUMMARY OF SIMILARITIES AND DIFFERENCES

The intended use and indications for use of the proposed Picasso Plus and Picasso Lite Plus devices are unchanged from the legally marketed predicate devices Picasso and Picasso Lite. The fundamental scientific technology of the proposed devices is unchanged from the legally marketed predicate device. The design changes implemented in the Picasso Plus and Picasso Lite Plus were aimed at improving functionality and enhancing user experience. The predicate devices and submitted devices share similar design features including identical wavelength, operating controls, and laser delivery method. The devices share similar methods of control systems, safety features, and operation. The devices share similar performance specifications including power output and energy type.

### XI. CONCLUSIONS

The Picasso Plus and Picasso Lite Plus lasers are substantially equivalent to the listed predicate devices (Picasso and Picasso Lite lasers) without raising any new issues of safety or effectiveness. The new devices have the same intended use and operating principles, with similar design features, and functional and performance characteristics. The device is designed to comply with relevant federal and international safety and performance standards.