The Fraxel re:pair (Fraxel III SR) Laser System, including its resurfacing handpiece delivery system, is intended for use in:
-Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue.
-Treatment of wrinkles, rhytides, furrows, fine lines;
-Pigmented lesions;
-Textural irregularities;
-Vascular dyschromia.
The Fraxel re:pair (Fraxel III SR) Laser System, including its incisional and debulking delivery systems, are intended for ablation (removal), for the reduction, treatment and/or removal of:
- Actinic and seborrheic keratoses;
-Chelitis;
-Cutaneous horns;
-Hemangiomas;
-Keloids;
-Nevi, including spider, epidermal and protruding;
-Rhinophyma;
-Syringomas;
-Warts;
-Laser incision and/or excision for the performance of upper and lower eyelid blepharoplasty and vermilionectomy of the lip.
The Fraxel re:pair Laser System consists of a CO2 laser source and three delivery handpieces for resurfacing, incision and debulking procedures. Each handpiece attaches to an articulating arm. Additional device accessories include interchangeable resurfacing treatment tips, incisional handpiece spatulas, and debulking handpiece spatulas.
The provided text is a 510(k) summary for the Fraxel re:pair (Fraxel III SR) Laser System and Accessories. It focuses on establishing substantial equivalence to previously marketed devices (K063038, K071051, K022060, K030147) rather than presenting a study with specific acceptance criteria and detailed performance metrics for this particular device.
Therefore, the information required to populate the tables and answer the questions regarding acceptance criteria and a study proving the device meets those criteria is largely not present in the provided document. The document describes clinical performance data from "Non-Significant Risk and Investigational Device Exemption studies to support the clinical performance of the Fraxel re:pair Laser System and its resurfacing handpiece," but it does not provide details of these studies, such as specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
It states: "Substantial equivalence for the Fraxel re:pair Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indications for use statements and equivalent performance specifications." This indicates that the device's clearance is based on its similarity to existing cleared devices, not on a new, independent study with defined acceptance criteria for this specific iteration.
However, I will extract any relevant information that might vaguely touch upon the requested points, even if it doesn't fully fulfill the criteria.
Acceptance Criteria and Reported Device Performance
As noted, the document does not define specific, quantifiable acceptance criteria or provide a table of performance metrics for this new device's clinical performance. The substantial equivalence argument relies on the predicate devices having "equivalent performance specifications."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified directly in this document for the new device | The document states "Substantial equivalence for the Fraxel re:pair Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indications for use statements and equivalent performance specifications." This implies that the performance of the new device is considered equivalent to the predicate devices, which are already deemed safe and effective for their indications. |
Study Information (Based on available text)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The document mentions "Non-Significant Risk and Investigational Device Exemption studies," suggesting prospective clinical studies, but no details are given.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified in the provided document.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in the provided document.
-
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
- Not applicable/Not mentioned. This is a medical device (laser system) for dermatological procedures, not an AI-assisted diagnostic device typically subject to MRMC studies comparing human reader performance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not mentioned. This is a laser system, not an AI algorithm. Its performance is inherent to the device's physical operation.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified in the provided document. For clinical studies supporting laser systems, ground truth often involves clinical assessments, photographic documentation, and patient-reported outcomes related to the treated conditions (wrinkles, lesions, etc.).
-
The sample size for the training set
- Not applicable/Not mentioned. This is a hardware medical device, not an AI model that requires a training set in the conventional sense.
-
How the ground truth for the training set was established
- Not applicable/Not mentioned.
Summary of what is available in the document regarding studies:
The document briefly states: "Non-Significant Risk and Investigational Device Exemption studies to support the clinical performance of the Fraxel re:pair Laser System and its resurfacing handpiece." This confirms that clinical studies were performed, but the 510(k) summary itself does not provide the detailed study results, acceptance criteria, methodologies, or sample sizes of these studies. The substantial equivalence argument relies on the existence of these studies for the predicate device, or implicitly, for this device's performance being similar to the predicates.
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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 re:pair™ (Fraxel III SR) Laser System and Accessories Laser Surgical Instrument 878.4810 GEX General Surgery/Restorative Devices Class II
LEGALLY MARKETED PREDICATE DEVICES
Name: Fraxel re:pair (Fraxel III SR) Laser System and Accessories 510(k) #: K063038, K071051
Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) #: K022060, K030147
DEVICE DESCRIPTION
The Fraxel re:pair Laser System consists of a CO2 laser source and three delivery handpieces for resurfacing, incision and debulking procedures. Each handpiece attaches to an articulating arm. Additional device accessories include interchangeable resurfacing treatment tips, incisional handpiece spatulas, and debulking handpiece spatulas.
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INDICATION FOR USE STATEMENT
The Fraxel re:pair (Fraxel 111 SR) Laser System, including its resurfacing handpiece delivery system_is intended for use in:
-Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue.
-Treatment of wrinkles, rhytides, furrows, fine lines;
-Pigmented lesions;
-Textural irregularities:
- Vascular dyschromia.
The Fraxel re:pair (Fraxel III SR) Laser System, including its incisional and debulking delivery systems, are intended for ablation (removal), for the reduction, treatment and/or removal of:
- Actinic and seborrheic keratoses;
-Chelitis;
-Cutaneous horns;
-Hemangiomas;
-Keloids;
-Nevi, including spider, epidermal and protruding;
-Rhinophyma:
-Syringomas;
-Warts:
-Laser incision and/or excision for the performance of upper and lower evelid blepharoplasty and vermilionectomy of the lip.
SUBSTANTIAL EQUIVALENCE COMPARISON
Indications for Use
Substantial equivalence for the Fraxel re:pair Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indications for use statements and equivalent performance specifications.
Clinical Performance Data
Non-Significant Risk and Investigational Device Exemption studies to support the clinical performance of the Fraxel re:pair Laser System and its resurfacing handpiece. The substantial equivalence of the incisional and debulking handpieces supported the determination of safety and effectiveness for the Fraxel re:pair Laser System and Accessories. Unique device features do not introduce new issues of safety and effectiveness.
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Technological Characteristics
Key technological characteristics for the resurfacing, incisional and debulking delivery systems for the Fraxel re:pair Laser System, such as energy type and operating principle, are equivalent to the Fraxel re:pair Laser System as described in submissions K063038 and K071051 and to the Lumenis Ultrapulse Encore Laser System as described in K020660 and K030147.
CONCLUSION
Based on the design, materials, function, specifications and intended use, the 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/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 2008
Reliant Technologies, Inc. % Ms. Heather MacFalls Clinical and Regulatory Affairs 464 Ellis Street Mountain View, California 94043
Re: K080915
Trade/Device Name: Fraxel re:pair (Fraxel III 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: March 31, 2008 Received: April 02, 2008
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 (QS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 M. Wilkinson
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): K080915
Fraxel re:pair (Fraxel !!! SR) Laser System and accessories Device Name: Indications For Use:
The Fraxel re:pair (Fraxel III SR) Laser System, including its resurfacing handpiece delivery system, is intended for use in:
-Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. -Treatment of wrinkles, rhytides, furrows, fine lines;
-Pigmented lesions;
-Textural irregularities;
-Vascular dyschromia.
The Fraxel re:pair (Fraxel II) SR) Laser System, including its incisional and debulking delivery systems, are intended for ablation (removal), for the reduction, treatment and/or removal of:
- Actinic and seborrheic keratoses:
-Chelitis:
-Cutaneous horns:
-Hemangiomas;
-Keloids;
-Nevi, including spider, epidermal and protruding;
-Rhinophyma;
-Syringomas:
-Warts;
-Laser incision and/or excision for the performance of upper and lower eyelid blepharoplasty and vermilionectomy of the lip.
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
Neuro:ion. Iu sea
- of D918
§ 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.