CUTERA TABLETOP AESTHETIC PRODUCT

K042165 · Cutera, Inc. · ILY · Oct 18, 2004 · Physical Medicine

Device Facts

• Record ID: K042165
• Device Name: CUTERA TABLETOP AESTHETIC PRODUCT
• Applicant: Cutera, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Oct 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Cutera Titan Tabletop Product with an infrared handpiece is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Cutera Titan Tabletop Product may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Story

Device is infrared surgical instrument console; drives infrared handpiece emitting 850-3000 nm energy, filtered to 1100-1800 nm. Components: system console with control electronics/software, display panel, detachable handpiece with integrated skin cooling, footswitch, and remote interlock. Used in clinical settings; operated by trained personnel. Provides topical heating to elevate tissue temperature; intended for pain relief, muscle relaxation, and increased local circulation. Healthcare provider monitors output via control panel; device facilitates therapeutic thermal treatment.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and identical indications for use to predicate devices.

Technological Characteristics

Infrared lamp (21 CFR 890.5500); emission 850-3000 nm, filtered to 1100-1800 nm via coated glass filters. Includes integrated skin cooling in handpiece. System console with control electronics and software. Remote interlock safety feature. Class II device.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle/joint pain, stiffness, arthritis-associated joint pain, muscle spasms, minor sprains/strains, and minor muscular back pain; also indicated for temporary increase in local circulation and muscle relaxation.

Regulatory Classification

Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• Cutera Optional Infrared Handpiece (K033768)
• Cutera base console (K023954)

Submission Summary (Full Text)

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K042165 p1/2

Premarket Notification 510(k) Submission: Cutera Titan Tabletop Product

# Attachment 12 510(k) Summary for the Cutera Titan Tabletop Product

# I. General Information

| Submitter: | Cutera, Inc.<br>3240 Bayshore Boulevard<br>Brisbane, CA 94005 |
|------------|---------------------------------------------------------------|
|------------|---------------------------------------------------------------|

Kathy Maynor Contact Person:

Summary Preparation Date: September 17, 2004

## Names II.

| Device Names: | Cutera Titan Tabletop Product |
|------------------------------|-----------------------------------------------------|
| Primary Classification Name: | Laser Powered Surgical Instrument (and Accessories) |

# Predicate Devices UII.

- . Cutera Optional Infrared Handpiece
## IV. Product Description

The Cutera Titan Tabletop Product consists of a modified console designed to drive the infrared handpiece, which is an existing, FDA cleared attachment for the existing, FDA cleared laser. The handpiece is an infrared handpiece with a variable emission of 0.8 to 2.0 microns (850 - 3000 nm). The delivered wavelength is filtered to 1100nm - 1800nm via coated glass filters to eliminate the extraneous wavelengths.

The Cutera Titan Tabletop Product is comprised of five main components:

- a system console (including software and control electronics); t
- t a control and display panel;
- a detachable handpiece with integrated skin cooling; .
- a foot-operated exposure switch (footswitch); and .
- a remote interlock connector (disables emission when treatment room door is opened). .

The proximal end of the umbilical cable is semi-permanently attached to the laser system console and the distal end is permanently attached to the body of the delivery hand piece. This hand piece is removable by either the user or an authorized field service engineer for replacement at the proximal end.

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Premarket Notification 510(k) Submission: Cutera Titan Tabletop Product

#### V. Indications for Use

The Cutera Titan Tabletop Product with an infrared handpiece is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Cutera Titan Tabletop Product may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

#### VI. Rationale for Substantial Equivalence

The Cutera Titan Tabletop Product shares the same general indications for use, and therefore is substantially equivalent to the currently cleared infrared handpiece (K033768) and the currently cleared base console (K023954).

#### VII. Safety and Effectiveness Information

The indication for use is exactly the same as the previously cleared infrared handpiece (K033768).

Technologically, the Cutera Titan Tabletop Product is substantially equivalent to the listed predicate device. Therefore the risks and benefits for the Cutera Titan Tabletop Product are comparable to the predicate devices.

We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of this device.

# VIII. Conclusion

The Cutera Titan Tabletop Product was found to be substantially equivalent to the currently cleared infrared handpiece (K033768) and base console (K023954). The Cutera Titan Tabletop Product shares similar indications for use, design features, and similar functional features as, and thus are substantially equivalent to, the currently marketed predicate devices.

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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 features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

OCT 1 8 2004

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cutera, Inc. c/o Mr. Morten S. Christensen FDA Office Coordinator Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050

Re: K042165

Trade/Device Name: Cutera Titan Tabletop Product Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: September 28, 2004 Received: September 29, 2004

Dear Mr. Christensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave rowled your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abor naturing 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 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.

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Page 2 - Mr. Morten S. Christensen

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse FDA finding of substantial equivalence of your device to a legally premailed predicated. The 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 if you atent office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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

Enclosure

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Premarket Notification 510(k) Submission: Cutera Titan Tabletop Product

# Attachment 2 Indications For Use Statement as Requested by FDA

K042165 510(k) Number (if Known):

Device Name: Cutera Titan Tabletop Product

Indications For Use:

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joint pain associated with arthritis, in et the Titles Treulation Product may a joint pain associated with artimis, the Cutera Titan Titan Titan Troduct may also help muscle
the relaxation of muscles. In addition, the Cutera Titan Tanksely min the relaxation of muscles. In addinor muscular back pain.

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Division of General, Restorative, and Neurological Devices

**510(k) Number** K042165