CLINICAL LASETTE P-200

K033799 · Cell Robotics, Inc. · GEX · Dec 22, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K033799
• Device Name: CLINICAL LASETTE P-200
• Applicant: Cell Robotics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 22, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2

Intended Use

Ablation of skin for collecting capillary blood samples for subsequent analysis.

Device Story

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; used by healthcare professionals in clinical settings; output is a skin perforation for capillary blood collection; benefits patient by providing alternative to mechanical lancets for blood sampling.

Clinical Evidence

No clinical data provided; no nonclinical performance data provided.

Technological Characteristics

Portable, battery-operated laser device; produces single pulse of laser light for skin ablation; Class II device.

Indications for Use

Indicated for use by qualified healthcare professionals 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

• Cell Robotics, Inc. Lasette Plus

Submission Summary (Full Text)

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DEC 2 2 2003

K 033799

510(K) Summary

Cell Robotics' Clinical Lasette P-200 Laser Skin Perforator

This 510(K) Summary of safety and effectiveness for the Cell Robotic's Clinical Lasette P-200 Lascr Skin Perforator 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: | Cell Robotics, Inc. |
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| Address: | 2715 Broadbent Parkway NE<br>Albuquerque, NM 87107 |
| Contact Person: | Linda A. Blair, Assistant Quality Manager |
| Telephone: | [phone] Ext. 124<br>[phone] |
| Preparation Date: | 12-3-03 |
| Device Trade Namc: | Clinical Lasette P-200 |
| Common Name: | Laser skin perforator |
| Classification: | Class II |
| Legally Marketed Predicate Device: | Cell Robotics, Inc. Lasette Plus |
| Description of the Cell Robotic's<br>Lasette Laser Skin Perforator | The Cell Robotics Lasette laser skin perforator is a<br>portable battery operated laser device. The device<br>produces a single pulse of laser light which ablates<br>a small hole in the patient's fingertip comparable to<br>that produced by commonly used stainless steel<br>blood lancets. |
| Intended use | Ablation of skin for collecting capillary blood<br>samples for subsequent analysis. |
| Indications for use | The Cell Robotic's Lasette Laser Skin Perforator is<br>indicated for use by qualified healthcare<br>professionals for the perforation of skin to draw<br>capillary blood for screening purposes. |
| Contraindications for Use | The Lasette should not be used to collect samples<br>for use in analyzers that require complex sample<br>transfer procedures. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Cell Robotic's Clinical Lasette P-200 Laser<br>Skin Perforator is substantially equivalent to the<br>predicate device. |
| Additional Information: | None requested at this time |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2003

Ms. Linda A. Blair Assistant Quality Manager Cell Robotics, Inc. 2715 Broadbent Parkway NE, Suite A-E Albuquerque, New Mexico 87107

Re: K033799 Trade/Device Name: Clinical Lasette P-200 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 3, 2003 Received: December 5, 2003

Dear Ms. Blair:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 elcctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Linda A. Blair

This letter will allow you to begin marketing your device as described in your Section 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), please contact the 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 Manufacturers, International 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.

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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## INDICATION FOR USE STATEMENT

11 033799 510(k) Number:

Lasette Laser Skin Perforator Device Name: Trade Name: Clinical Lasette P-200

Indications for Use:

The Cell Robotic's Clinical Lasette P-200 Laser Skin Perforator is indicated for use by qualified healthcare professionals for the perforation of skin to draw capillary blood for screening purposes.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Cila W

sion of General, Restorative · Neurological Device

10033799

Prescription Use
(per 21 CFR 801.109)

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Over-the-Counter Use