(94 days)
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.
The DuraLITE-GL is an exact replacement component for the Candela GentleLASE Plus fiber optic.
Here's a breakdown of the acceptance criteria and study information for the DuraLITE-GL, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria (Explicitly Stated or Implied) | Reported Device Performance |
|---|---|---|
| Physical | Not explicitly stated, but implied to be equivalent to predicate. | Testing validated that the performance of the DuraLITE-GL is identical to the fiber optic components manufactured by Candela for the GentleLase family of lasers. |
| Optical | Not explicitly stated, but implied to be equivalent to predicate. | Testing validated that the performance of the DuraLITE-GL is identical to the fiber optic components manufactured by Candela for the GentleLase family of lasers. |
| Connectivity | Not explicitly stated, but implied to be equivalent to predicate. | Testing validated that the performance of the DuraLITE-GL is identical to the fiber optic components manufactured by Candela for the GentleLase family of lasers. |
| Environmental | Not explicitly stated, but implied to be equivalent to predicate. | Testing validated that the performance of the DuraLITE-GL is identical to the fiber optic components manufactured by Candela for the GentleLase family of lasers. |
| Clinical Equivalence | The DuraLite-GL must be able to be used as a replacement part for all procedures as cleared by the FDA for the Candela GentleLase family of lasers. | The submission concludes the DuraLITE-GL is substantially equivalent to other existing fiber optic components in commercial distribution for use in Dermatology and Plastic Surgery, based on physical, optical, connectivity, and environmental testing. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for a "test set" in the context of clinical or diagnostic performance. The testing described is for physical, optical, connectivity, and environmental performance of the device itself, rather than evaluating a diagnostic algorithm on a dataset.
Data Provenance: Not applicable in the context of this type of device and testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is an accessory to a laser, and the "ground truth" for its performance is related to its physical and functional equivalence to the predicate device, not clinical outcomes directly. No experts in a clinical "ground truth" capacity are mentioned for the test set.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
No MRMC comparative effectiveness study was done. This document describes a replacement component for a laser, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical component, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" in this context is the performance of the legally marketed predicate device (Candela GentleLASE Plus Fiber Optic). The study aimed to demonstrate that the DuraLITE-GL's physical, optical, connectivity, and environmental performance was "identical" to this predicate.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical component, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set is involved.
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AUG 1 3 2004
Attachment I 510(K) Summary DuraLITE-GL
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 |
|---|---|
| Address: | Laser Scientific115 Sundance Parkway # 230BRound 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, laser79-GEX, 21 CFR 878-48 |
| Legally Marketed Predicate Device: | GentleLASE Plus Fiber Optic cleared under K024371, K024260,K024335, K994260, K984601K003460 |
| Description of the DuraLITE-GL | The DuraLITE-GL is an exact replacement component for theCandela GentleLASE Plus fiber optic. |
| Intended use of the DuraLITE-GL | The DuraLite-GL is a replacement fiber optic component for theCandela GentleLASE family of lasers. |
| The DuraLite-GL may be used as a replacement part for allprocedures as cleared by the FDA for the Candela GentleLasefamily of lasers. | |
| Performance Data: | Physical, Optical, Connectivity and Environmental testing havebeen performed. Testing validates that the performance of theDurLite-GL I identical to the fiber optic componentsmanufactured by Candela for the GentleLase family of lasers. |
| Results of Clinical Study: | None |
| Conclusion: | The DuraLITE-GL is substantially equivalent to other existingfiber optics components in commercial distribution for use inDermatology 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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)
Muriane C. Provost
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_K 64/26 2
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.