(251 days)
Not Found
No
The device description focuses on the physical components and user-controlled parameters of a laser system, with no mention of AI, ML, image processing, or data-driven decision-making.
Yes.
The device is used for cutting, vaporization, and ablation of soft tissue, including tattoo removal and treatment of benign pigmented lesions, which are therapeutic applications. It also explicitly mentions in its conformity to IEC60601-2-22 "Particular requirements for safety of diagnostic and Therapeutic laser" that it is a therapeutic laser.
No
The device is indicated for cutting, vaporization, and ablation of soft tissue, including tattoo removal and treatment of benign pigmented lesions. These are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines multiple hardware components including a laser system, articulated arm, handpiece, power supply, optical chamber, and LCD screen. It is a physical laser system, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The RUBY STAR Laser Q-switched 694mm Ruby laser system is a therapeutic device that uses laser energy to directly interact with soft tissue for procedures like cutting, vaporization, ablation, and tattoo/pigmented lesion removal. It operates on the body, not on specimens from the body.
- Intended Use: The intended use clearly describes direct treatment of soft tissue, not the analysis of biological samples.
Therefore, based on the provided information, the RUBY STAR Laser system is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
RUBY STAR Laser Q -switched 694mm Ruby laser system is indicated for cutting, vaporization, and ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.
Product codes
GEX
Device Description
RUBY STAR Q-switched laser system are emitting a beam of coherent light at 694nm with 25-30ns Pulse width, and 0.1 - 200j/cm2 Energy fluence via 7-Articulated arm and consist of
-
- An articulated arm delivery systems terminated in a hand piece.
-
- Electronic power supply and interface circuitry
-
- Optical chamber with laser rod and cavity optics with cooling system.
-
- LCD color touch screen with foot pedal switch.
Laser energy produced is delivered to the Tissue by means of an articulated arm.
The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch.
- LCD color touch screen with foot pedal switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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
Clinical and Non-Clinical performance test data was not provided in this submission. But, manufactured in accordance with both mandatory and voluntary standard as below
IEC60601-1 part 1 : General requirement for basic safety and essential performance.
IEC60601-1-2: 2007: EMC test
IEC60601-2-22 Part 2: Particular requirements for safety of diagnostic and Therapeutic laser
IEC60825-1 :2nd ED: Equipment classification and requirement.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a stylized eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2015
Bison Medical Company, Ltd % Mr. Young Chi Bio-Med USA Incorporated 27 New England Drive Ramsey, New Jersey 07446
Re: K150997 Trade/Device Name: RUBY STAR Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: November 17, 2015 Received: November 24, 2015
Dear Mr. Chi:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Binita S. Ashar -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150997
Device Name Ruby Star
Indications for Use (Describe)
RUBY STAR Laser Q -switched 694mm Ruby laser system is indicated for cutting, vaporization, and ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Prepared Dec 22. 2015
510 (K) Summary
As required by CFR 807.92(c)
1. Manufacture.
Reg Nr: 3011555967
Bison Medical Co, Ltd. Ace High-end tower 6, #1801/1802 234 Beotkkot-ro, Gasan dong GeumCheon -gu, Seoul 153-798, Rep of Korea 82 2 865 7121, f: 82 2 865 7131
2. Submitter and Contact person
Bio-Med USA Inc. Young Chi, President. 27 New England Drive, Ramsey, NJ 07446. U.S.A. t: 1-973 278 5222 f: 1 201 934 6030 e mail: biomedusa@msn.com
3. Name of Device
| Trade name : | RUBY STAR |
|---|---|
| Classification name : | Powered, Laser surgical instrument |
| Common name : | Ruby laser |
| Regulation : | 878.4810 |
| Class II | |
| Classification Panel : | General and Plastic Surgery. |
| Product Code : | GEX |
4. Legally marketed Predicate Device
K990902 MLT R694 Medical laser Technologies All characteristics such as Design, Construction, Energy, Repetition rate, Cooling System, Intended use of wave length 694nm are substantially equivalent to the predicate device.
5. Device Description
RUBY STAR Q-switched laser system are emitting a beam of coherent light at 694nm with 25-30ns Pulse width, and 0.1 - 200j/cm2 Energy fluence via 7-Articulated arm and consist of
-
- An articulated arm delivery systems terminated in a hand piece.
-
- Electronic power supply and interface circuitry
-
- Optical chamber with laser rod and cavity optics with cooling system.
-
- LCD color touch screen with foot pedal switch.
Laser energy produced is delivered to the Tissue by means of an articulated arm.
4
The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch.
6. Performance test
Clinical and Non-Clinical performance test data was not provided in this submission. But, manufactured in accordance with both mandatory and voluntary standard as below
IEC60601-1 part 1 : General requirement for basic safety and essential performance. IEC60601-1-2: 2007: EMC test IEC60601-2-22 Part 2: Particular requirements for safety of diagnostic and Therapeutic laser IEC60825-1 :2nd ED: Equipment classification and requirement.
Proposed device, demonstrates no significant difference compared to the predicate device
7. Indication for use.
RUBY STAR Laser Q -switched 694nm Ruby laser system is indicated for Cutting,
Vaporization, Ablation of Soft Tissue. This includes Tattoo Removal and treatment of Benign Pigmented Lesions.
8. Biocompatibility, Sterilization
This device are non-contacted mode. Hand piece tips are made by same material as the predicate device.
9.Conclusion.
RUBY STAR Q-Switched 694nm Ruby laser System, in this submission, is substantially equivalent to several already cleared predicate device in respect to the Intended use, main function, Technology, Principal operation and performance. and every safety test report show it as safe and effective as predicate device and it does not raise any additional issues for safety and effectiveness.