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510(k) Data Aggregation
(403 days)
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(281 days)
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(90 days)
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(218 days)
The device is intended to be used with endoscopic accessories such as a biopsy forceps and Electronic Endoscope Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.
The Flexible Ureterorenoscope System consists of a sterile Flexible Ureterorenoscope and an Electronic Endoscope Image Processor with its accessories power adapter. The Flexible Ureterorenoscope is provided sterile (sterilized by EO) and is single use.
The Flexible Ureterorenoscope consists of a head section, bending section, insertion section, operating section, electrical connection section, and built-in LED light source. The Electronic Endoscope Image Processor is powered by the main line.
The Flexible Ureterorenoscope is an endoscope instrument and is intended to be used with the Electronic Endoscope Image Processor during endoscopic procedures. The handle section features several key components, including a control lever, a handle for manipulation, a button for capturing photos or video, and a Luer port for the insertion of accessories or irrigation to the working channel.
The insertion section houses a working channel and wiring to transmit the image signals to the image processor. The distal bending section of the insertion section contains a camera lens for real-time image capture, an LED light source for illumination, and a distal outlet for the working channel.
The Electronic Endoscope Image Processor is a video processor which is intended and designed for use during endoscopic procedures. It receives and processes image signals from the endoscope and outputs signals to an external medical monitor for display.
The Electronic Endoscope Image Processor has integrated software to control the operation of the device and is a reusable device that does not require sterilization before use, as there is no direct/in-direct patient contact material. The image processor is intended to be cleaned and disinfected before use, the cleaning and disinfection method is validated and recommend in the User Manual.
The equipment is for use in a hospital or qualified medical institution. It is only to be used by skilled physicians trained in clinical endoscopic techniques and procedures.
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(91 days)
Diode Laser Hair Removal Machine (Model: GLD01) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Diode Laser Hair Removal Machine (Model: GLD01) consists with the power system, microprocessor controller system, operation and screen system, cooling system, laser module and security alarm system. The microprocessor control the laser power, which can provide the constant current for the laser module. The inner high energy diode, from the laser module, transform the electronic to light energy, which output the constant laser with wavelength.The laser light on the skin by leaded crystal, penetrate into the deep tissue of the skin. The light energy is absorbed and then turned into the thermal energy, which can destroy the hair follicle tissue, make it gone and never grow again.
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(90 days)
The Q-Renew LLLT Hair Growth Helmet is indicated for the promotion of hair growth in males who have Norwood-Hamilton classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.
The Q-Renew LLLT Hair Growth Helmet is a non-invasive, at-home low-level laser/light therapy (LLLT) device designed to promote hair growth in both men and women. It uses a dual light system that combines laser diodes (wavelength 655nm) with LEDs (wavelengths 630nm, 660nm, and 680nm) to deliver optimal light absorption by the scalp.
The device consists of a Q-Renew LLLT helmet, a charging base and a USB-C charging cable.
The helmet features an adjustable fit, controlled by a rear adjustment wheel, and an intuitive LCD screen for operation. Users can:
- Start or pause treatments
- Select treatment zones
- Check battery status
- View remaining session time
The helmet has a power button for turning the device on/off. The device also includes smart sensors—removing the helmet automatically pauses the session, while repositioning it resumes treatment. Each session lasts 12 minutes, after which the device stop the treatment automatically.
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(33 days)
The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older and as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.
The SER Pen Carain MicroSystem is a handheld powered microneedling device consisting of a rechargeable motorized handpiece and disposable, single-use needle cartridges (12-pin and 36-pin). Microneedles are made of surgical-grade stainless steel (304) and are gamma sterilized.
Design modifications include:
- Addition of a powered 7-speed control head (6,200–9,000 RPM) with direct corded power option.
- Modified disposable cartridge (Model T2.0), shortened by 7 mm, with protective cap and compensatory spring.
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