(196 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on laser technology and an embedded processor for control.
Yes
The device is intended for dermatological procedures and treatments that aim to improve health or well-being by altering the body's structure or function. This includes coagulation of soft tissue, treatment of wrinkles, photocoagulation of pigmented lesions, and skin resurfacing.
No
The device is described as a laser system for dermatological procedures involving soft tissue coagulation, treatment of wrinkles, photocoagulation of pigmented lesions, and skin resurfacing. Its function is to deliver thermal energy for treatment, not to diagnose conditions.
No
The device description explicitly states it consists of "a set of fiber lasers, controlled by an embedded processor," and uses "scanning and focusing optics," indicating it is a hardware-based laser system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to in vivo procedures performed directly on the patient's skin (dermatological procedures, treatment of wrinkles, photocoagulation of lesions, skin resurfacing). IVDs are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health.
- Device Description: The description details a laser system that delivers thermal energy to the epidermis and upper dermis. This is a therapeutic device, not a diagnostic one.
- No mention of analyzing biological samples: There is no indication that this device is used to analyze any type of biological specimen.
Therefore, the Reliant Laser System II is a therapeutic medical device used for dermatological procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"The Reliant Laser System II is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and dyschromia;
Skin resurfacing procedures."
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Reliant Laser System II consists of a set of fiber lascrs, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal cnergy to the cpidermis and upper dermis. Device accessories include tip attachments 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)
Clinical analysis was conducted on Non-Significant Risk and IDE Roliant studies to support the change in the language in the indications for use statement. Sufficient safety and efficacy data has been gathered to detenmine that the Roliant Lasor II $ ystem performs as clinically intended and that no new issues of safety and effectiveness are ntroduced.
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.
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
Reliant Technologies, Inc.
. ﻧﻮﻣﺒﺮ
1 | 3
Premarket Notification:
| K042319 | Reliant Laser II System and Accessories, Labeling Change |
|---|---|
| MAR 10 2005 |
- 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
REGULATORY AUTHORITY
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT
| Heather Tanner | |
|---|---|
| Reliant Technologies, Inc. | |
| 260 Sheridan Ave. | |
| Palo Alto, CA 94306 | |
| 650 473-0200, 103 | |
| 650 473-0537 fax | |
| htanner@reliant-tech.com |
NAME OF DEVICE
| Trade Name: | Reliant Laser II System and Accessories (Fraxel SR Laser System) |
|---|---|
| Common Name: | Laser Surgical Instrument |
| Regulation Number | 878.4810 |
| Product code: | GEX |
| Device Panel: | General Surgery/Restorative Devices |
| Device Classification: | Class II |
PREDICATE DEVICES
| Name: Reliant Laser System II | |
|---|---|
| 510(k) #: K040617 | |
| Name: Reliant Laser System | |
| 510(k) #: K031795 | |
| Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories | |
| 510(k) #: K022060 |
1
Reliant Technologies, Inc.
2/3 042319
DEVICE DESCRIPTION
The Reliant Laser System II consists of a set of fiber lascrs, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal cnergy to the cpidermis and upper dermis. Device accessories include tip attachments and pre-treatment solution.
INDICATION FOR USE STATEMENT
The Reliant Laser System II is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
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
Technological Characteristics
There has been no change to the Reliant Tcchnologics Laser System II. The system is identical to the Reliant Technologics 510(k)s cleared under 510(k) K031795 and K040617.
Indications for Use
Substantial equivalence for the Reliant Laser II System is supported by the predicate devices listed in this submission, which have identical or similar indication statements.
Clinical Performance Data
Clinical analysis was conducted on Non-Significant Risk and IDE Roliant studies to support the change in the language in the indications for use statement. Sufficient safety and efficacy data has been gathered to detenmine that the Roliant Lasor II $ ystem performs as clinically intended and that no new issues of safety and effectiveness are ntroduced.
2
Reliant Technologies, Inc. Coup J 319 3/3
Premarket Notification: Reliant Laser II System and Accessories, Labeling Change
CONCLUSION
Based on the design, materials, function, intended use and clinical evaluation, the Reliant Based on the design, materials, Inneable, misalent to the devices currently Laso II System and Accessories IS Mostantially eqtic Act. Safety and effectiveness are marketed under the Foderal FOOG, 17ttig and Connect or being made in the laser reasonably assured, justifying >10(k) cicannee, rro onazged and clections performance data
or accessories. The technical, mechanical, performance, and cleared by this or accessories. The technical, mechanical, performatio, and unaffected by this change in labeling.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2005
Ms. Heather Tanner Clinical Research/Regulatory Affairs Manager Reliant Technologies, Inc. 260 Sheridan Avenue, Suite 309 Palo Alto, California 94306
Re: K042319
R042317
Trade/Device Name: Reliant Laser System II and Accessories (Fraxel SR Laser System) 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: December 7, 2004 Received: December 10. 2004
Dear Ms. Tanner:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your because roges for device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary the Medical Device Amendments, or to commerce pror to May 20, 11:37 | 11 accordance with the provisions of the Federal Food, DINE, de necs that here boon require approval of a premarket approval application (PMA). and Cosmetic Herefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mains of the Act include requirements for annual registration. Iisting of general controls provider in a practice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it rr your de vice is one additional controls. Existing major regulations affecting your device can may oc subject to satin adallarian legulations. 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 tease be advised that i Drivies and on over device complies with other requirements of the Act that 1197 has intact a and regulations administered by other Federal agencies. You must on any I 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 CI K Fat 6077, labeling (2 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic forth in the quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Ms. Heather Tanner
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin mankemig your antial equivalence of your device to a legally premarket nothication. The PDA midning of substantal. Popularian Por your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (1 CFR Part 80) ), please If you desire specific advice tor your ac not of the same of the regulation entitled. contact the Office of Compliance at (210) 216 - 101 (21CFR Part 807.97). You may obtain "Misbranding by relevence to premarket notifications in the Act from the Division of Snall other general information on your responsible in the live in the mumber (800) 638-204 or Manufacturers, International and Consulter Forse and Consectivindustry/support/index.html.
Sincerely yours,
sincerely yours,
Mark A. Wilkinson
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
910(k) Number (if known): K042319
Device Name: Reliant Laser System II and Accessories (Fraxel SR Laser System)
Indications For Use:
"The Reliant Laser System II is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) 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 ANDTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
mali A. Millheez
(Division Sign-Off)
al, Restorative. and Neurological Devices
510(k) Number K042319