ERBIUM 2000 LASER FAMILY

K972915 · Phantom Technologies, Inc. · GEX · Dec 19, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972915
• Device Name: ERBIUM 2000 LASER FAMILY
• Applicant: Phantom Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Erbium 2000 laser family is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include: general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures.

Device Story

Erbium 2000 laser family (Models A-E) provides surgical soft tissue management; includes laser console, articulated arm, handpiece, control panel, finger/foot trigger, laser head, CPU, power supply, and cooling system. Operates at 5-50 Watts average power. Used by physicians in clinical/surgical settings for excision, incision, ablation, vaporization, and coagulation. CPU control system manages laser output; physician directs beam via handpiece to target tissue. Output allows precise tissue removal or resurfacing; benefits include controlled surgical intervention across multiple specialties.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and adherence to performance standards (UL544, UL2601.1, IEC601.1, IEC825, 21 CFR 1040.10 & 1040.11).

Technological Characteristics

Powered surgical laser system; 5-50 Watts average power. Components: laser console, articulated arm, handpiece, CPU control, power supply, internal cooling. Standards: UL544, UL2601.1, IEC601.1, IEC825, 21 CFR 1040.10/11. Connectivity: standalone console with manual controls.

Indications for Use

Indicated for surgical excision, incision, ablation, vaporization, and coagulation of soft tissue and skin resurfacing in patients requiring such procedures across various surgical specialties including general, plastic, aesthetic, dermatology, urology, gynecology, ENT, pulmonary, thoracic, podiatry, oral/maxillofacial, ophthalmology, and arthroscopy.

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

• Pfizer (k904627)
• Pfizer (k905802)
• Schwartz Electro Optics (k954013)
• Coherent (k960032)
• Continuum Biomedical (k961748)
• Aesculap-Meditec (k964128)
• Fotana/Candela (k962902)
• Laserscope (k964016)
• ESC Medical (k964532)
• Coherent (k963339)
• Coherent (k951812)
• Coherent (k912029)

Submission Summary (Full Text)

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K972915

DEC 1 9 1997

## 510(k) Summary Statement

| Applicant: | Phantom Technologies, Inc.<br>845 Commercial Avenue<br>Palo Alto, California 94303 | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | James A. Nations<br>Phone: [phone]<br>Fax: [phone] | |
| Device Name: | Erbium 2000<br>Model A<br>Model B<br>Model C<br>Model D<br>Model E | |
| Class of the device and panel: | Class II<br>Instrument, surgical, powered, laser<br>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 system family with<br>substantial equivalence. | |
| Predicate Devices: | Pfizer<br>Pfizer<br>Schwartz Electro Optics<br>Coherent<br>Continuum Biomedical<br>Aesculap-Meditec<br>HGM<br>Fotana/Candela<br>Laserscope<br>ESC Medical<br>Coherent<br>Coherent<br>Coherent<br>Laserscope | k904627<br>k905802<br>k954013<br>k960032<br>k961748<br>k964128<br>Unknown<br>k962902<br>k964016<br>k964532<br>k963339<br>k951812<br>k912029<br>Unknown |

Device Description:

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Phantom Erbium lasers are composed of the following components:

- a laser console .
- a counterbalanced articulated arm and handpiece .
- a control / display panel ●
- a finger trigger or foot petal control ●
- ● a laser head w / beam optics
- a CPU control system
- . a power supply
- an internal cooling system

Models range from 5 to 50 Watts average power.

Indications For Use:

The Erbium 2000 laser family is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include: general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, with the negative space forming a human profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 19 1997

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

Re: K972915

Trade Name: Erbium 2000 Laser Family, Models A, B, C, D, and E Regulatory Class: II Product Code: GEX Dated: November 13, 1997 Received: November 19, 1997

Dear Mr. Nations:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Nations

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

focollpe

Celia 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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Page I of of i

510(k) Number (if known):_K972915

Device Name: ERBIUM 2000 LASER FAMILY

Indications For Use:

The Erbium 2000 laser family is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include: general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="Signature" src="signature.png"/> |
|-----------------------------------------|--------------------------------------------|
| | (Division Sign-Off) |
| Division of General Restorative Devices | |
| 510(k) Number | K972915 |

| Prescription Use | <span style="text-decoration: overline;">X</span> | OR | Over-The-Counter Use | ____________________ |
|----------------------|---------------------------------------------------|----|--------------------------|----------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) | |