TRU-PULSE CO2 SURGICAL LASER

K970804 · Tissue Technologies, Inc. · GEX · Jun 3, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970804
• Device Name: TRU-PULSE CO2 SURGICAL LASER
• Applicant: Tissue Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.

Device Story

Tru-Pulse CO2 Surgical Laser is an RF-excited gas-slab pulsed CO2 laser system. It delivers 1-10 watts of average power for surgical applications. Operated by physicians in clinical settings, the device is used for coagulation, vaporization, ablation, or cutting of soft tissue. The laser energy interacts with tissue to achieve the desired surgical effect, assisting the surgeon in performing procedures across various specialties including dermatology, plastic surgery, podiatry, and otorhinolaryngology.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

RF-excited gas-slab pulsed CO2 laser; 1-10 watts average power output. Class II device (21 CFR 878.48).

Indications for Use

Indicated for coagulation, vaporization, ablation, or cutting of soft tissue in patients undergoing procedures in dermatology, plastic surgery, general surgery, podiatry, and otorhinolaryngology.

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

• UltraPulse® Pulsed CO₂ Laser (Coherent)

Submission Summary (Full Text)

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K970804

# Attachment I

510(K) Summary

Tru-Pulse CO2 Surgical Laser System

JUN - 3 1997

This 510(K) Summary of safety and effectiveness for the Tissue Technologies, Inc. Tru-Pulse™ CO2 Surgical Laser system is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

| Applicant:
Address: | Tissue Technologies, Inc.
4432 Anaheim NE
Albuquerque, NM 87113 |
| --- | --- |
| Contact Person: | Sandra Hansen, Regulatory Affairs |
| Telephone: | [phone]
[phone] |
| Preparation Date: | 3-1-97 |
| Device Trade Name: | Tru-Pulse™ CO2 Surgical Laser |
| Common Name: | CO2 Surgical Laser |
| Classification Name: | Instrument, Surgical, Powered, laser
79-GEX
21 CFR 878-48 |
| Legally Marketed Predicate Device: | UltraPulse® Pulsed CO₂ Laser manufactured by Coherent |
| Description of the Tru-Pulse™ CO2 Surgical Laser | Tru-Pulse™ Pulsed CO2 Surgical laser is an Rf excited gas-slab pulsed CO2 laser which produces 1-10 watts average power |
| Intended use of the Tru-Pulse™ CO2 Surgical Laser | This intended use is the same or similar to that for the UltraPulse® Pulsed CO₂ Laser manufactured by Coherent, i.e. "clinical applications in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology, arthroscopy, open and endoscopic general surgery. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The intended us is the same or similar to that for the UltraPulse Pulsed CO2 laser marketed by Coherent, i.e.: Clinical applications in dermatology, plastic surgery., podiatry., neurosurgery, gynecology, otorhinolaryngology, arthroscopy, open and endoscopic general surgery. |
| Additional Information: | None requested at this time |

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 3 1997

Ms. Sandra Hansen
Regulatory Affairs
Tissue Technologies, Inc.
4432 Anaheim NE
Albuquerque, New Mexico 87113

Re: K970804
Trade Name: Tru-Pulse™ CO2 Surgical Laser
Regulatory Class: II
Product Code: GEX
Dated: March 1, 1997
Received: March 4, 1997

Dear Ms. Hansen:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Sandra Hansen

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,


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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# INDICATION FOR USE STATEMENT

510(k) Number: K970804

Device Name: Tru-Pulse™ CO2 Surgical Laser

Indications for Use:

Coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.

(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 ☐