LASETTE

K983673 · Cell Robotics, Inc. · GEX · Jan 15, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K983673
• Device Name: LASETTE
• Applicant: Cell Robotics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2

Intended Use

Ablation of skin for collecting capillary blood samples for subsequent analysis

Device Story

Lasette is a portable, battery-operated laser device; produces single pulse of laser light to ablate small hole in patient's fingertip; replaces traditional stainless steel blood lancets for capillary blood collection. Used for screening purposes; contraindicated for samples requiring complex transfer procedures. Clinical trials under IDEs confirmed safety and effectiveness.

Clinical Evidence

Three human clinical trials conducted under approved Investigational Device Exemptions (IDEs). Results indicated the device is safe and effective for its intended use.

Technological Characteristics

Portable, battery-operated laser device. Principle of operation: laser ablation of skin tissue. Form factor: handheld device.

Indications for Use

Indicated for the perforation of skin to draw capillary blood for screening purposes.

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

• Laser Lancet (TransMedica International)

Submission Summary (Full Text)

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K 983673

## 510(K) Summary Cell Robotic's Lasette Laser Skin Perforator

This 510(K) Summary of safety and effectiveness for the Cell Robotic's Laser Skin Perforator its I his 310(K) Summary of Saley and encerents of the Ser Room Following guidance concerning the organization and content of a 510(K) summary.

| Applicant: | Cell Robotics, Inc. |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 2715 Broadbent Parkway NE<br>Albuquerque, NM 87107 |
| Contact Person: | Connie White, Manager of Regulatory Affairs |
| Telephone: | [phone] Ext. 108<br>[phone] |
| Preparation Date: | 10-3-98 |
| Device Trade Name: | Lasette |
| Common Name: | Laser skin perforator |
| Classification: | Class II |
| Legally Marketed Predicate Device: | Laser Lancet manufactured by TransMedica International,<br>323 Center Street, Suite 1100, Little Rock, AR 72201. |
| Description of the Cell Robotic's Lasette<br>Laser Skin Perforator | The Cell Robotics Lasette laser skin perforator is a portable<br>battery operated laser device. The device produces a single<br>pulse of laser light which ablates a small hole in the patient's<br>fingertip comparable to that produced by commonly used<br>stainless steel blood lancets. |
| Intended use | Ablation of skin for collecting capillary blood samples for<br>subsequent analysis |
| Indications for use | The Cell Robotic's Laser Skin Perforator is indicated<br>for use for the perforation of skin to draw capillary blood for<br>screening purposes |
| Contraindications for Use | The Lasette should not be used to collect samples for use in<br>analyzers that require complex sample transfer procedures. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | The subject device has been investigated in three human<br>clinical trials under approved Investigational Device<br>Exemptions. Results from the clinical trials indicate that the<br>device is safe and effective. |

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## Conclusion:

The Cell Robotic's Lasette Laser Skin Perforator is substantially equivalent to the predicate device.

・

Additional Information:

None requested at this time

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 1999

Mr. Ronald K. Lohrding President and Chief Executive Officer Cell Robotics, Inc. 2715 Broadbent Parkway, Northeast Albuquerque, New Mexico 87107

K983673 Re:

> Trade Name: Cell Robotics Lasette Laser Skin Perforator Regulatory Class: II Product Code: GEX Dated: October 13, 1998 Received: October 20, 1998

Dear Mr. Lohrding:

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. Ronald K. Lohrding

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 vours.

Sincerely yours,

Jocasta

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

983673 New Submission 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Lasette Laser Skin Perforator Device Name:

Indications for Use:

The Cell Robotic's Lasette Laser Skin Perforator is indicated for use for the perforation of skin to draw capillary blood for screening purposes.

(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__________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)

Division of General Restorative Devices
510(k) Number K983673