(203 days)
Not Found
No
The summary describes a laser system for dermatological procedures and does not mention any AI or ML components or functionalities.
Yes
The device is used for the treatment of various dermatological conditions, which aligns with the definition of a therapeutic device.
No
This device is described as a laser system for "ablation (removal), resurfacing and coagulation of soft tissue" and for "Treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia." Its function is therapeutic, not diagnostic.
No
The device description explicitly states it consists of a "laser source" and "scanning and focusing optics," which are hardware components, not software.
Based on the provided information, the Fraxel III SR Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Fraxel III SR Laser System is a therapeutic device. Its intended use is for dermatological procedures requiring ablation, resurfacing, and coagulation of soft tissue, and for treating various skin conditions like wrinkles, pigmented lesions, and vascular dyschromia. It directly interacts with the patient's tissue for treatment purposes, not for analyzing samples outside the body.
The description clearly indicates a laser system used for direct treatment on the skin, which is the opposite of how IVD devices function.
N/A
Intended Use / Indications for Use
The Fraxel III SR (Fraxel re:pair™) Laser System is intended for use in: Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Treatment of wrinkles, rhytides, furrows, fine lines, texture irregularities, pigmented lesions and vascular dyschromia.
Product codes
GEX
Device Description
The Fraxel III SR Laser System consists of a laser source which delivers a pattern of thermal energy to the epidermis and dermis using scanning and focusing optics. Device accessories include interchangeable treatment tips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Significant Risk and Investigational Device Exemption studies support the clinical performance of the Fraxel III SR (Fraxel re:pair) Laser System. Sufficient clinical data supported the determination of safety and effectiveness for the Fraxel III SR (Fraxel re:pair) Laser System and Accessories. The device performed as clinically intended with no new issues of safety and effectiveness introduced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K053047, K050841, K042319, K040617, K031795, K062303, K063038, K022060, K030147
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
07105
NOV = 2 2007
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
REGULATORY AUTHORITY
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT
Heather MacFalls Reliant Technologies, Inc. 464 Ellis St. Mountain View, CA 94043 650 605-2257 650 605-2057 fax hmacfalls@fraxel.com
NAME OF DEVICE
Trade Name:
Common Name: Regulation Number Product code: Device Panel: Device Classification: Fraxel III SR Laser System (Fraxel re:pair™) and Accessories Laser Surgical Instrument 878.4810 GEX General Surgery/Restorative Devices Class II
LEGALLY MARKETED PREDICATE DEVICES
Name: Fraxel SR Laser System and Accessories 510(k) #: K053047, K050841, K042319, K040617 and K031795
Name: Fraxel II SR Laser System and Accessories 510(k) #: K062303
Name: Fraxel III SR Lascr System and Accessories 510(k) #: K063038
Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) #: K022060, K030147
DEVICE DESCRIPTION
The Fraxel III SR Laser System consists of a laser source which delivers a pattern of thermal energy to the epidermis and dermis using scanning and focusing optics. Device accessories include interchangeable treatment tips.
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0710j1
INDICATION FOR USE STATEMENT
The Fraxel III SR (Fraxel re:pair™) Laser System is intended for use in:
Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue.
Treatment of wrinkles, rhytides, furrows, fine lines, texture irregularities, pigmented lesions and vascular dyschromia.
SUBSTANTIAL EQUIVALENCE COMPARISON
Indications for Use
Substantial equivalence for the Fraxel III SR (Fraxel re:pair) Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indication statements.
Clinical Performance Data
Non-Significant Risk and Investigational Device Exemption studies support the clinical performance of the Fraxel III SR (Fraxel re:pair) Laser System. Sufficient clinical data supported the determination of safety and effectiveness for the Fraxel III SR (Fraxel re:pair) Laser System and Accessories. The device performed as clinically intended with no new issues of safety and effectiveness introduced.
Technological Characteristics
Key technological characteristics of the Fraxel III SR (Fraxel re:pair) Laser System, such as energy type and operating principle, are equivalent to the Fraxel SR Laser System as described in submissions K053047, K050841, K042319, K040617 and K031795, to the Fraxel II SR Laser System as described in K062303 and to the Lumenis Ultrapulse Encore Laser System as described in K020660 and K030147.
CONCLUSION
Based on the design, materials, function, intended use and clinical evaluation, the Fraxel III (Fraxel re:pair) Laser System and Accessories is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. Safety and effectiveness are reasonably assured, justifying 510(k) clearance.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a graphic representation of a human figure, with three abstract shapes forming the head, body, and legs. The logo is simple and recognizable, representing the department's focus on health and human well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 2007
Reliant Technologies, Inc. % Ms. Heather MacFalls Clinical and Regulatory Affairs 464 Ellis Street Mountain View, California 94043
Re: K071051
Trade/Device Name: Fraxel III SR Laser System (Fraxel re:pair™) 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: August 1, 2007 Received: August 7, 2007
Dear Ms. MacFalls:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
3
Page 2 - Ms. Heather MacFalls
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) 276-0120. 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,
For Off- Oct 06
li.17
Mark N. Melkerson Director Division of General, Restorative. and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Fraxel III SR Laser System (Fraxel re:pair™) and Accessories Device Name: Indications For Use:
"The Fraxel III SR Laser System and accessories is intended for use in:
Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue.
Treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia."
Prescription Use X (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)
No
Division Si
Division Sign-Of Division of General, Restorative age 1 of 1 and Neurological Devices
510(k) Number `co7105