(108 days)
Not Found
No
The summary describes a laser system controlled by an embedded processor for delivering thermal energy. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is intended for "Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Treatment of acne scars and surgical scars; Photocoagulation for treatment of dyschromia and pigmented lesions...; Skin resurfacing procedures," which are all therapeutic in nature.
No
The device description and intended use indicate that the Fraxel® SR 1500 Laser System is used for therapeutic dermatological procedures, such as coagulation of soft tissue, treatment of wrinkles and scars, photocoagulation, and skin resurfacing. It does not mention any function for diagnosis or detection of diseases.
No
The device description explicitly states it consists of a fiber laser and embedded processor, indicating it is a hardware-based system with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes dermatological procedures performed on the patient's skin (epidermis and dermis) for treatment purposes. IVDs are used to examine specimens from the body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a laser system that delivers thermal energy to the skin. This is a therapeutic device, not a diagnostic one that analyzes biological samples.
- Anatomical Site: The anatomical site is the epidermis and dermis, which are parts of the living patient's body being treated directly.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the Fraxel® SR 1500 Laser System is a therapeutic medical device used for dermatological treatments, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fraxel® SR1500 Laser System 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 for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma: Skin resurfacing procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Fraxel® SR1500 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 controlled pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K062303, K060310, K050841, K022060
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
070284
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
REGULATORY AUTHORITY
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT
Heather Tanner MacFalls Reliant Technologies, Inc. 464 Ellis St. Mountain View, CA 94043 650 605-2257 phone 650 605-2057 fax hmacfalls@fraxel.com
NAME OF DEVICE
Trade Name: Common Name: Regulation Number Product code: Device Panel: Device Classification: Fraxel® SR1500 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® II SR Laser System and Accessories 510(k) #: K060310
Name: Fraxel® SR Laser System and Accessories 510(k) #: K050841
Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) #: K022060
DEVICE DESCRIPTION
The Fraxel® SR1500 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
MAY 1 7 2007
1
070284
to deliver a controlled pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.
INDICATION FOR USE STATEMENT
The Fraxel® SR1500 Laser System 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 for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma:
Skin resurfacing procedures.
SUBSTANTIAL EQUIVALENCE COMPARISON
Indications for Use
Substantial equivalence for the Fraxel® SR1500 Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indication statements. The clinical performance data reviewed supported the determination that the Fraxel® SR1500 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® SR1500 Laser System, such as energy type and operating principle, are identical to the Fraxel® SR1500 Laser System as described in submission K062303.
CONCLUSION
Based on the evaluation described herewithin, the Fraxel® SR1500 Laser System and Accessories is substantially equivalent to the predicate devices currently marketed in accordance with the Federal Food, Drug and Cosmetic Act. Safety and effectiveness were reasonably assured, justifying 510(k) clearance.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
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
MAY 1 7 2007
Re: K070284
Trade/Device Name: Fraxel® SR 1500 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: April 12, 2007 Received: May 4, 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 (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.
3
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.
y yours.
Mark N. Mull
M rk 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): ヒロフロスタイ
Fraxel® SR 1500 Laser System and accessories Device Name:___ Indications For Use:
"The Fraxel® SR 1500 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 for treatment of dyschromia and pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis and melasma;
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 Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, and Neurological Devices | Page 1 of _______ |
| 510(k) Number | L070284 |