HEADLAMP HL2000.

K994362 · Angiolaz, Inc. · FSR · May 11, 2000 · Ophthalmic

Device Facts

• Record ID: K994362
• Device Name: HEADLAMP HL2000.
• Applicant: Angiolaz, Inc.
• Product Code: FSR · Ophthalmic
• Decision Date: May 11, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4335
• Device Class: Class 2

Intended Use

The Headlamp HL2000 has indicated use in the following situations: There is a requirement for illuminating a surgical field. There is a requirement for illuminating a surgical field. The doctor wears this device on his/her head. The headlamp contains a fiber optic cable which connects at one end to a remote light source and the other end to the headlamp contains a lens system which focuses the light into a circular spot and illuminates the surgical field.

Device Story

HeadLamp HL2000 is a surgical illumination device worn on the clinician's head. It consists of a head-mounted assembly connected via a fiber optic cable to a remote light source. The system directs light through a lens system to project a circular spot onto the surgical field. Used in clinical or surgical settings by physicians to improve visibility during procedures. The device provides localized, adjustable illumination to assist in clinical decision-making and surgical accuracy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Head-mounted surgical light; fiber optic cable delivery; remote light source; lens system for circular spot projection. Class II device (Product Code FSR).

Indications for Use

Indicated for use by physicians requiring illumination of a surgical field during medical procedures.

Regulatory Classification

Identification

An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.

Special Controls

*Classification.* (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 11 2000

Mr. Robert Allman Senior Project Leader Angiolaz, Inc. P.O. Box 556 Industrial Park Bellows Park, Vermont 05101

Re: K994362 Trade Name: HeadLamp, HL2000 Regulatory Class: II Product Code: FSR Dated: March 7, 2000 Received: March 7, 2000

Dear Mr. Allman:

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 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 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 - Mr. Robert Allman

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,

Dianne R. Lochner.

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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Page__________________________________________________________________________________________________________________________________________________________________________ o (

## 510(k) Number (il known):_K 994362

Device Name: HEADLAMP HL2000____

Indications For Use:

Device Name: HeadLamp, HL2000 Indications for use:

The Headlamp HL2000 has indicated use in the following situations:

There is a requirement for illuminating a surgical field. .

· There is a requirement for munimaling on and The doctor wears this device on hishler end to the headlamp. The headlamp contains a
end to a remote light source and the other end to the headlamp contains a End to a remote inght source and the carcular spot and illuminates the surgical field.

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--|--------------------------------------------------------|
|--|--------------------------------------------------------|

| | <p><u>Anne R. Lochner</u></p> <p>(Division Sign-Off)</p> <p>Division of General Restorative Devices</p> <p>510(k) Number: K994362</p> |
|--|---------------------------------------------------------------------------------------------------------------------------------------|
|--|---------------------------------------------------------------------------------------------------------------------------------------|

| Prescription Use | |
|----------------------|--------------------------|
| (Per 21 CFR 801.109) | |
| OR | Over-The-Counter Use |
| | (Optional Format 1-2-96) |