(126 days)
The Fraxel IV SR Laser System and accessories is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Treatment of acne scars and surgical scars;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia;
Skin resurfacing procedures.
The Fraxel IV SR Laser System consists of a fiber laser, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the skin.
The provided text for K063808 is a 510(k) summary of safety and effectiveness for a medical device (Fraxel IV SR Laser System and Accessories). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the new device meets specific, novel acceptance criteria through a dedicated study.
Therefore, the document does not contain the information requested for a detailed breakdown of acceptance criteria and a study proving the device meets them.
Here's why and what information is contained:
- No Acceptance Criteria or Device Performance Table: The document does not define specific performance metrics or acceptance criteria for the Fraxel IV SR Laser System. Instead, it relies on demonstrating that its indications for use and technological characteristics are substantially equivalent to already approved predicate devices.
- No Dedicated Study to Prove Criteria: Because no new, specific acceptance criteria are presented for this device, there is no study described that aims to prove the device meets such criteria. The "Clinical Performance Data" section merely states, "Sufficient safety data has been gathered to determine that the Fraxel IV Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced." This is a general statement, not a detailed study report.
- No Information on Sample Sizes, Data Provenance, Expert Ground Truth, or Adjudication: Since there isn't a detailed study described for this device, there is no information about sample sizes for test sets, data provenance, the number or qualifications of experts, or adjudication methods.
- No MRMC or Standalone Study Information: The document does not mention any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance studies. The Fraxel IV SR is a physical laser system, not an AI or imaging diagnostic tool.
- No Ground Truth Type or Training Set Information: As there's no diagnostic or analytical algorithm being evaluated, the concepts of ground truth (expert consensus, pathology, outcomes data) and training sets are not applicable or discussed in this context.
In summary, the provided 510(k) pertains to demonstrating substantial equivalence, not to presenting a study proving a device meets specific quantitative acceptance criteria.
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KO6 3808
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
REGULATORY AUTHORITY
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT
APR 2 7 2007
Heather T. MacFalls Reliant Technologies, Inc. 464 Ellis St. Mountain View, CA 94043 650 605-2257 650 605-2057 fax hmacfalls@reliant-tech.com
NAME OF DEVICE
Trade Name: Common Name: Regulation Number Product code: Device Panel: Device Classification: Fraxel IV SR Laser System and Accessories Laser Surgical Instrument 878.4810 GEX General Surgery/Restorative Devices Class II
LEGALLY MARKETED PREDICATE DEVICES
Name: Fraxel II SR Laser System and Accessories 510(k) #: K062303
Name: Fraxel SR Laser System and Accessories 510(k) #: K050841
DEVICE DESCRIPTION
The Fraxel IV SR Laser System consists of a fiber laser, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the skin.
INDICATION FOR USE STATEMENT
The Fraxel IV SR Laser System is intended for use in:
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K06 3/08
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Treatment of acne scars and surgical scars;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and dyschromia;
Skin resurfacing procedures.
SUBSTANTIAL EQUIVALENCE COMPARISON
Indications for Use
Substantial equivalence for the Fraxel IV SR Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indication statements.
Clinical Performance Data
Sufficient safety data has been gathered to determine that the Fraxel IV Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced.
Technological Characteristics
Key technological characteristics of the Fraxel IV SR Laser System, such as energy type and operating principle, are equivalent to the Fraxel II SR Laser System as described in submission K062303 and the Fraxel SR Laser System as described in submission K053047.
CONCLUSION
Based on the design, materials, function, intended use and clinical evaluation, the Fraxel IV Laser System and Accessories is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. No changes are being made in the laser wavelength or operating principle. Safety and effectiveness are reasonably assured, justifying 510(k) clearance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Reliant Technologies, Inc. % Ms. Heather MacFalls Director of Regulatory and Clinical Affairs 464 Ellis Street Mountain View, California 94043
APR 2 7 2007
Re: K063808
Trade/Device Name: Fraxel IV SR Laser System and accessories 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: February 28, 2007 Received: March 1, 2007
Dear Ms. MacFalls:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Heather MacFalls
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
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):
Device Name: Fraxel IV SR Laser System and accessories Indications For Use:
"The Fraxel IV SR Laser System and accessories is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Treatment of acne scars and surgical scars;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia;
Skin resurfacing procedures."
Prescription Use × (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 Eraluation (ODE)
Stan-Off
l. Restorative, and Neurologica age 1 of
510(k) Number
§ 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.