DERMATHERM 100

K980607 · New Star Lasers, Inc. · ILY · Apr 3, 1998 · Physical Medicine

Device Facts

• Record ID: K980607
• Device Name: DERMATHERM 100
• Applicant: New Star Lasers, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Apr 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dermatherm 100 is indicated for use to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.

Device Story

Dermatherm 100 is an infrared heat lamp; emits infrared energy to provide topical heating; elevates or maintains tissue temperature. Device intended for clinical use; operated by healthcare personnel. Output is thermal energy; used to provide therapeutic heat to patient tissue. Benefits include localized warming for therapeutic purposes.

Clinical Evidence

No clinical data; no non-clinical performance data provided.

Technological Characteristics

Infrared heat lamp; therapeutic device (21 CFR 890.5500); product code ILY. No specific materials, connectivity, or software algorithms described.

Indications for Use

Indicated for patients requiring topical heating to elevate or maintain tissue temperature via infrared energy emission.

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

• Warm-Lamp (K932881)

Submission Summary (Full Text)

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APR - 3 1998

Kg80•607

Attachment I 510(K) Summary Dermatherm 100

This 510(K) Summary of safety and effectiveness for the Dermatherm 100 is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the Organization and content of a 510(K) summary. ﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ !

| Applicant: | New Star Lasers |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 11802 Kemper Road<br>Auburn, CA 95603 |
| Contact Person: | Nina Davis |
| Telephone: | [phone]<br>[phone] FAX |
| Preparation Date: | 1-15-98 |
| Device Trade Name: | Dermatherm 100 |
| Common Name: | Infrared Heat Lamp |
| Classification Name: | Therapeutic Device<br>Product Code IL Y<br>21CFR Regulation: 890.5500 |
| Legally Marketed Predicate Device: | Warm-Lamp is manufactured by Olympic Medical, cleared under<br>510(K) number K932881. |
| Description of the Dermatherm 100: | See Attachment II |
| Intended use of the Dermatherm 100: | The Dermatherm 100 is indicated for use to emit energy in the<br>Infrared Spectrum to provide topical heating for the purpose of<br>elevating and/or maintaining tissue temperature. |
| Non-clinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Dermatherm 100 is substantially equivalent to other existing<br>Heat Lamps in commercial distribution. |
| Additional Information: | None requested at this time |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 1998

Mr. Dave Fullmer ·New Star Lasers, Inc. 11802 Kemper Road Auburn, California 95603

Re: K980607 Trade Name: Dermatherm 100 Regulatory Class: II Product Code: ILY Dated: January 4, 1998 Received: January 17, 1998

Dear Mr. Fullmer:

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. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement; as set .................................................................................................................. forth in the Quality System Regulation (QS) 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. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 - Mr. Dave Fullmer

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: New submission

Device Name Dermatherm 100

Indications for Use:

The Dermatherm 100 is indicated for use to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH Office of Device Evaluation (ODE)

Acceul

11 : 11 : 11 510(k) Num

.

Over-the Counter Use \$\not\$

Prescription Use (per 21 CFR 801.109)

OR