SCANTECH LASER SCANNER

K974633 · Phantom Technologies, Inc. · GEX · Jan 16, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974633
• Device Name: SCANTECH LASER SCANNER
• Applicant: Phantom Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Phantom ScanTech handpiece is intended to be used with the Phantom Family of Medical Lasers to deliver a broad spectrum of laser light energy for use in surgical applications generally requiring the ablation, vaporization, excision, incision and coagulation of soft tissue in a variety of medical specialties.

Device Story

ScanTech is a laser accessory handpiece used with Phantom Family Medical Lasers; delivers laser light energy for soft tissue surgery. System includes handpiece with dual galvo X-Y scanning, control/power cable, laser control/display panel, CPU-based laser control system, and CPU-controlled power supply. Physician or assistant selects pattern shape, size, and density via laser's interactive touch screen. Device applies computer-controlled patterns to tissue; enables precise ablation, vaporization, excision, incision, coagulation, and photothermolysis. Used in clinical settings (general, plastic, aesthetic surgery, dermatology, ophthalmology). Output allows controlled tissue interaction, improving surgical precision and efficiency compared to manual laser delivery.

Clinical Evidence

Bench testing only. Device performance verified against UL544, UL2601.1, IEC601.1, IEC825, and 21 CFR 1040.10 & 1040.11 standards. No clinical data provided.

Technological Characteristics

Handpiece with dual galvo X-Y scanning mechanism; CPU-based control system; removable spatula-bayonet tip; screw ring attachment for articulated arm. Energy source: Phantom Family Medical Lasers. Standards: UL544, UL2601.1, IEC601.1, IEC825, 21 CFR 1040.10/1040.11.

Indications for Use

Indicated for surgical excision, incision, ablation, vaporization, coagulation, and photothermolysis of soft tissue. Specialties include general, plastic, and aesthetic surgery, dermatology, and ophthalmology (limited to periorbital dermis).

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

• Coherent (K960032, K951812, K943604, K962242)
• Clinicon (K964520, K955734, K941841)
• Laserscope Sahar (K964684, K961935, K960820, K960521)
• Sharplan (K955621)

Submission Summary (Full Text)

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|<974633

JAN 16 1998

## 510(k) SUMMARY STATEMENT

| Applicant: | Phantom Technologies, Inc.<br>845 Commercial Avenue<br>Palo Alto, California 94303 |
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| Contact<br>Phone:<br>Fax: | James A. Nations<br>650-493-9155<br>650-493-9146 |
| Manufacturing Facility: | Phantom Technologies, Inc.<br>845 Commercial Avenue<br>Palo Alto, California 94303 |
| Establishment<br>Registration Number: | Applied for, not yet received |
| Device Name: | ScanTech |
| Common Name: | Laser accessory; scanner |
| Device Class: | II<br>Instrument, laser accessory |
| Panel: | 79-GEX<br>21 CFR 878.48 |
| Performance Standards: | UL544, UL2601.1, IEC601.1, IEC825<br>21 CFR 1040.10 & 1040.11 |
| Reason for submission: | New laser accessory with substantial<br>equivalence. |
| Product Description: | The Phantom ScanTech handpiece is intended to be used with the<br>Phantom Family of Medical Lasers to deliver a broad spectrum of<br>laser light energy for use in surgical applications generally requiring<br>the ablation, vaporization, excision, incision and coagulation of soft<br>tissue in a variety of medical specialties. |
| | The Phantom ScanTech handpiece is composed of the following<br>main components:<br>Handpiece with dual galvo X - Y scanning capabilities Control / power cable Laser control / display panel interface CPU based Laser control system CPU controlled power supply Removable spatula-bayonet tip Screw ring attachment for articulated arm |

Used in conjunction with the Phantom Family of Medical Lase

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automated scanning device to accurately and quickly apply computer-controlled patterns of various shapes and sizes. The Physician, or his/her assistant, will select the desired shape, size and density, as well as other operating parameters, from the Phantom laser's interactive touch screen. Predicate Devices: Coherent k960032, k951812, k943604 k962242 Clinicon k964520, k955734, k941841 Laserscope Sahar k964684 k961935, k960820, k960521, Sharplan K955621

Indications For Use:

The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation and photo thermolysis of soft tissue in medical specialties including: general surgery, plastic surgery, aesthetic surgery, dermatology, ophthalmology including, but not limited to use in oculoplasty.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 16 1998

Mr. James A. Nations Director, Regulatory Affairs Phantom Technologies, Incorporated 845 Commercial Avenue Palo Alto, California 94303

Re: K974633 Trade Name: ScanTech Laser Scanner Regulatory Class: II Product Code: GEX Dated: December 9, 1997 Received: December 12, 1997

Dear Mr. Nations

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System -Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for

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Page 2 - Mr. Nations

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807,97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Sincerely yours,

a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN): K974633

DEVICE NAME:

INDICATIONS FOR USE:

The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation and photo thermolysis of soft tissue in medical specialies including: general surgery, plastic surgery, aesthetic surgery, dermatology, ophthalmology (timited to periobital dermis).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)

Signature of

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974633