(92 days)
Not Found
No
The description focuses on the laser technology and its physical components, with no mention of AI or ML.
No
The device is used for cosmetic purposes (tattoo removal, hair removal) and treating benign pigmented lesions, which are not typically considered therapeutic interventions for a disease or condition.
No
The device description indicates its purpose is to remove tattoos, lesions, and hair, and not to diagnose any condition.
No
The device description clearly indicates it is a physical laser system with a console, articulated arm, handpieces, and footswitch, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for procedures performed on the patient's body (removing tattoos, pigmented lesions, and hair). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description details a laser system that delivers energy to the patient's skin. This is consistent with a therapeutic or aesthetic device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the Polaris Long Pulse and Q-Switched Ruby Laser is a therapeutic/aesthetic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Polaris Long Pulse and Q-Switched Ruby Laser is intended to remove blue/black tattoos and benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Polaris Long Pulse and Q-Switched Ruby Laser and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Energy is delivered using an articulated arm with interchangeable handpieces to adjust spot size. The wavelength is 694.3nm. The user activates laser by means of a footswitch.
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)
None
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
K 12.1162
. ↑
Attachment 5 510(K) Summary Polaris Long Pulse and Q-Switched Ruby Laser
،
This 510(K) Summary of safety and effectiveness for Polaris Long Pulse and Q-Switched Ruby Laseris submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) sümmary.
| Applicant: | Sandstone Medical Technologies, LLC | JUL 18 2012 |
|---|---|---|
| Address: | 105 Citation Court | |
| Birmingham, AL 35209 | ||
| Contact Person: | Mark Rohrer | |
| Telephone: | 205-290-8251 - phone | |
| Email: | ssmed@bellsouth.net | |
| Preparation Date: | March 30, 2012 | |
| Device Trade Name: | Polaris Long Pulse and Q-Switched Ruby Laser | |
| Common Name: | Long Pulse and Q-Switch Laser | |
| Classification Name: | Instrument, Surgical, Powered, laser | |
| 79-GEX, 21 CFR 878-48 | ||
| Legally Marketed | ||
| Predicate Device: | LaseAway Long Pulse and Q-Switched Ruby Laser (K)971193 | |
| Description of the Polaris | ||
| Long Pulse and Q- | ||
| Switched Ruby Laser | The Polaris Long Pulse and Q-Switched Ruby Laser | |
| and controls are contained in a single console. Electrical power | ||
| is supplied to the console by the facility's power source. Energy | ||
| is delivered using an articulated arm with interchangeable | ||
| handpieces to adjust spot size. The wavelength is 694.3nm. | ||
| The user activates laser by means of a footswitch. | ||
| Intended use: | The Polaris Long Pulse and Q-Switch Ruby Laser is intended | |
| to remove blue/black tattoos and benign dermal and epidermal | ||
| pigmented lesions, and, to effect hair removal of patients with | ||
| skin types 1-4 through selective targeting of melanin in hair | ||
| follicles in dermatology and plastic surgery | ||
| Performance Data: | None | |
| Results of Clinical Study: | None | |
| Conclusion: | The Polaris Long Pulse and Q-Switched Ruby Laser | |
| is identical to the predicate device in terms of indications for | ||
| use, technical specifications, operating performance features, | ||
| general design. |
1
Attachment 5 510(K) Summary Polaris Long Pulse and Q-Switched Ruby Laser
Technical Specifications Comparison
| | Polaris Long Pulse and Q-Switched Ruby Laser | LaseAway Q-Switch Ruby
(Predicate Device) |
|--------------------------------|----------------------------------------------|----------------------------------------------|
| Laser | Pulsed Ruby (Single lamp) | Pulsed Ruby (Single lamp) |
| Size | H840 mm x W495 mm x D680
mm | H840 mm x W495 mm x D680
mm |
| Weight | 125Kg | 125Kg |
| Power requirement | 110V/220V 50/60 Hz (16A peak) | 110V/220V 50/60 Hz (16A peak) |
| Cooling | Self contained refrigerated
chiller | Self contained refrigerated
chiller |
| Cooling medium | De-ionised water | De-ionised water |
| Wavelength | 694.3nm | 694.3nm |
| Aiming beam, HeNe | 633nm | 633nm |
| Repetition rate | 1Hz | 1Hz |
| Pulse duration, Q-
Switched | 25 ns | 25 ns |
| Pulse duration, Long
Pulse | 2ms | 2ms |
| Maximum energy Q-
Switched | 1.25 joules | 1.25 joules |
| Maximum energy, Long
Pulse | 5 joules | 5 joules |
| Spot size, Q-Switched | Selectable from 4, 5 and 6mm | Selectable from 4, 5 and 6mm |
| Spot Size, Long Pulse | Selectable from 5. 6 and 7mm | Selectable from 5. 6 and 7mm |
| Beam delivery | Articulated arm and focusing
handpiece | Articulated arm and focusing
handpiece |
| Ambient conditions | 15° to 26°C, 10 to 80% humidity | 15° to 26°C, 10 to 80% humidity |
: ・
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sandstone Medical Technologies, LLC % Mr. Mark Rohrer 105 Citation Court Homewood, Alabama 35209
JUL 18 2012
Re: K121162
Trade/Device Name: Polaris Long Pulse and Q-Switched Ruby Laser 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: June 30, 2012 Received: July 06, 2012
Dear Mr. Rohrer:
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
3
Page 2 - Mr. Mark Rohrer
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Eunice Keith
S Mark N. Melkerson Director. Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K121162 510(k) Number (if known): ____
Device Name: Polaris Long Pulse and Q-Switched Ruby Laser
The Polaris Long Pulse and Q-Switched Ruby Laser is intended to remove blue/black tattoos and benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
Prescription Use XX (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)
Neil R.P. Order for mxm
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121162