DURALITE-GL

K041262 · Laser Scientific · GEX · Aug 13, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041262
• Device Name: DURALITE-GL
• Applicant: Laser Scientific
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2

Intended Use

The DuraLite-GL is a replacement fiber optic component for the Candela GentleLASE family of lasers. The DuraLite-GL may be used as a replacement part for all procedures as cleared by the FDA for the Candela GentleLase family of lasers.

Device Story

DuraLITE-GL is a replacement fiber optic component for Candela GentleLASE laser systems. It functions as a passive delivery accessory to transmit laser energy from the source to the treatment site. Used in dermatology and plastic surgery settings by trained clinicians. Device serves as a direct replacement for original equipment manufacturer (OEM) fiber optics; ensures identical optical and physical performance to maintain the safety and efficacy of the host laser system during clinical procedures.

Clinical Evidence

No clinical data. Bench testing only, including physical, optical, connectivity, and environmental testing, demonstrated performance identical to the predicate fiber optic components.

Technological Characteristics

Passive fiber optic component; dimensions and materials designed to be an exact replacement for Candela GentleLASE fiber optics. No energy source, software, or electronic components.

Indications for Use

Indicated for use as a replacement fiber optic component for the Candela GentleLASE family of lasers for all procedures cleared by the FDA for that laser family. Patient population is defined by the cleared indications of the Candela GentleLASE system.

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

• GentleLASE Plus Fiber Optic (K024371, K024260, K024335, K994260, K984601, K003460)

Submission Summary (Full Text)

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## AUG 1 3 2004

## Attachment I 510(K) Summary DuraLITE-GL

K041262

This 510(K) Summary of safety and effectiveness for the Dural.ITE-GL 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: | Laser Scientific |
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| Address: | Laser Scientific<br>115 Sundance Parkway # 230B<br>Round Rock, TX 78681 |
| Contact Person: | Mr. John Crownover |
| Telephone: | 1-512-733-8709 |
| Preparation Date: | May 1, 2004 |
| Device Trade Name: | DuraLITE-GL |
| Common Name: | Accessory to a Laser Device |
| Classification Name: | Instrument, Surgical, Powered, laser<br>79-GEX, 21 CFR 878-48 |
| Legally Marketed Predicate Device: | GentleLASE Plus Fiber Optic cleared under K024371, K024260,<br>K024335, K994260, K984601K003460 |
| Description of the DuraLITE-GL | The DuraLITE-GL is an exact replacement component for the<br>Candela GentleLASE Plus fiber optic. |
| Intended use of the DuraLITE-GL | The DuraLite-GL is a replacement fiber optic component for the<br>Candela GentleLASE family of lasers. |
| | The DuraLite-GL may be used as a replacement part for all<br>procedures as cleared by the FDA for the Candela GentleLase<br>family of lasers. |
| Performance Data: | Physical, Optical, Connectivity and Environmental testing have<br>been performed. Testing validates that the performance of the<br>DurLite-GL I identical to the fiber optic components<br>manufactured by Candela for the GentleLase family of lasers. |
| Results of Clinical Study: | None |
| Conclusion: | The DuraLITE-GL is substantially equivalent to other existing<br>fiber optics components in commercial distribution for use in<br>Dermatology and Plastic Surgery. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

AUG 1 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Crownover General Manger Laser Scientific 115 Sundance Parkway, #230B Round Rock, Texas 78681

Re: K041262 Trade/Device Name: DuraLite-GL 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: May 1, 2004 Received: May 17, 2004

Dear Mr. Crownover:

We have reviewed your Section 510(k) premarket notification of intent to market the device we neve roviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ase stated in the energy, 1976, the enactment date of the Medical Device Amendments, or to eoninered prior co rity 2011-12-12 in accordance with the provisions of the Federal Food, Drug, de noes mat have been room do not require approval of a premarket approval application (PMA). and Cosmette For ( 100 ) 100 ( 100 ) 100 ) 100 general controls provisions of the Act. The r ou may not sprovisions of the Act include requirements for annual registration, listing of general controls proficiting 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 It your de rios 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 r lease oc devilode that i Dr unation that your device complies with other requirements of the Act that I 127 has Intacted and regulations administered by other Federal agencies. You must or any I cachi statutes and registements, including, but not limited to: registration and listing (21 Comply with an the Not 21 CFR Part 801): good manufacturing practice requirements as set CI K Fart 607); adoling (21 CFR Part 820); and if applicable, the electronic form in and quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. John Crownover

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ough finding of substantial equivalence of your device to a legally promatics notheadon: "The PDF 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 If you desire specific acrepliance at [phone]. Also, please note the regulation entitled, Connect the Office of Court County of Court (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

Miriam C. Provost

1 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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## Indications for Use

510(k) Number (if known): K K C (k) 202

Device Name: DuraLite-GL___________________________________________________________________________________________________________________________________________________________________

Indications For Use:

## The DuraLite-GL is a replacement fiber optic component for the Candela GentleLASE family of lasers.

The DuraLite-GL may be used as a replacement part for ail procedures as cleared by the FDA for the Candela GentleLase family of lasers.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Muriane C. Provost

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

510(k) Number_K 64/26 2