(88 days)
Not Found
MLT R694.LaseAway Long Pulse and Q-Switched Ruby Laser, MM-Ruby, Laser; Sectrum RD 1200; Candela AlexLazar, MLT R694, EpiLaser, Chromos 694, Sharplan EpiTouch
No
The document describes a laser system with different operating modes and intended uses, but there is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is described as treating conditions like unwanted body hair, tattoos, and benign pigmented lesions, which falls under the definition of a therapeutic device as it treats or manages medical conditions or symptoms.
No
The device's intended uses are to remove unwanted body hair and for cutting, vaporization, or ablation of soft tissue, including tattoo removal and treatment of benign pigmented lesions. These are therapeutic and aesthetic uses, not diagnostic.
No
The device description clearly states it is a "laser system" which emits a beam of coherent light, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Ruby Star's Function: The Ruby Star laser system is used to directly interact with the human body for procedures like hair removal, tattoo removal, and treatment of pigmented lesions. It does not analyze specimens taken from the body.
The description clearly indicates the device is a therapeutic laser system used for external procedures on the patient.
N/A
Intended Use / Indications for Use
The laser system Ruby Star (operating in normal use) is intended to remove unwanted body hair.
The laser system Ruby Star (operating in Q-Switch mode) is indicated for cutting, vaporization, or ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.
Some examples of pigment lesions are:
Lentigines, Cafe-au-lait-blotches, Ephalides, Benign Naevi such as Nevus of Ota, Naevus of Ito, Epidermal naevi, Congenital naevi, Becker's naevi, Blue naevus, Naevus spilus, and Mongolian spot.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The laser system RubyStar operates as a normal pulse or as a Q-Switched ruby laser which emits a beam of coherent light at 694 nanometers. In Q-Switched mode the beam has much shorter pulse duration than in the normal pulse mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, body hair
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed professionals in the United States
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)
None. The specifications and intended uses of the laser system RubyStar operating in Q-Switch or normal mode are the same or very similar to those of claimed predicate devices. Because of this , performance data were not required.
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.
Not Found
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.
MLT R694.LaseAway Long Pulse and Q-Switched Ruby Laser, MM-Ruby, Laser; Sectrum RD 1200; Candela AlexLazar, MLT R694, EpiLaser, Chromos 694, Sharplan EpiTouch
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
991285
JUL 1 2 1999
510(k) SUMMARY AESCULAP-MEDITEC GMBH LASER SYSTEM RubyStar WITH NORMAL AND Q-SWITCH MODE
This 510(k) summary of safety and effectiveness for the AESCULAP-MEDITEC GMBH Laser System RubyStar with normal and Q-Switch mode is submitted in accordance with the requirements of SDMA 1990 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.
AESCULAP-MEDITEC GMBH Applicant:
-
Prussinastrasse 41 Address: 07739 Jena, Germany
Contact Person: Dr. Dirk Colditz Quality Management Representative -
Phone: +49 3641 65 3453 Fax: +49 3641 65 3815 ctz@aesculap.meditec.com e-mail:
Preparation date: March 1999
Laser System RubyStar Device name:
RubyStar (with normal and Q-Switch mode) Common Name:
Classification Name:
Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810) Product code: GEX - Laser instrument, surgical, powered Panel: 79
Legally marketed: MLT R694.LaseAway Long Pulse and Q-Switched Ruby Laser, MM-Ruby, Laser; Sectrum RD 1200; Candela AlexLazar
- Description: The laser system RubyStar operates as a normal pulse or as a Q-Switched ruby laser which emits a beam of coherent light at 694 nanometers. In Q-Switched mode the beam has much shorter pulse duration than in the normal pulse mode.
Intended Use: The laser system RubyStar operating in normal mode is intended to remove unwanted body hair. The laser system RubyStar operating in Q-Switch mode is indicated for cutting, vaporization, or ablation of soft tissue. This includes tattoo removal and treatment of benign pigment lesions.
1
The specifications of the RubyStar laser in the Q-Switch mode Comparison to: are the same as or very similar to those of legally marketed lasers such as the MLT R694(Q-Switch mode), LaseAway Long Pulse and Q-Switched Ruby Laser, the MM-Ruby Laser; the Spectrum RD 1200, and the Candela AlexLAZR. The specifications of the RubyStar operating in normal mode are the same as or very similar to those of legally marketed lasers such as the MLT R694, EpiLaser, Chromos 694, and Sharplan EpiTouch.
- Performance data: None. The specifications and intended uses of the laser system RubyStar operating in Q-Switch or normal mode are the same or very similar to those of claimed predicate devices. Because of this , performance data were not required.
- When operating in Q-Switch or normal mode the RubyStar is CONCLUSION: substantially equivalent to legally marketed devices, e.g. ruby and alexandrite lasers, operating in both Q-Switch or normal mode.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1.2 1999
Mr. William Kelley Aesculap-Meditec North America 2525 McGaw Avenue Irvine, California 92623-9791
Re: K991285
Trade Name: Laser System Ruby Star (with normal and Q-Switch mode) Regulatory Class: II Product Code: GEX Dated: March 31, 1999 Received: April 15, 1999
Dear Mr. Kelley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. William Kelley
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
- Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(K) Number (if known): _ GS | 2 8 5
Device Name: Laser System Ruby Star (with normal and O-Switch mode)
Indications For Use Statement:
The laser system Ruby Star (operating in normal use) is intended to remove unwanted body hair.
The laser system Ruby Star (operating in Q-Switch mode) is indicated for cutting, vaporization, or ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.
Some examples of pigment lesions are:
Lentigines, Cafe-au-lait-blotches, Ephalides, Benign Naevi such as Nevus of Ota, Naevus of Ito, Epidermal naevi, Congenital naevi, Becker's naevi, Blue naevus, Naevus spilus, and Mongolian spot.
The laser system Ruby Star is restricted to sale or use by licensed professionals in the United States
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Division Sign-Off) Division of General Restorative Device 510(k) Number