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510(k) Data Aggregation
K Number
K250936Device Name
Q-Switched Nd:YAG Laser (SHE-LSP101-1)
Manufacturer
Date Cleared
2025-06-12
(76 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Beijing Sano Laser S&T Development Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Q-Swithched Nd:YAG Laser is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for for General Dermatology, Dermatologic and General Surgical Procedures as follows:
1064nm:
- Tattoo removal
- dark ink: blue and black
- Treatment of Benign Pigmented Lesions
- Nevus of ota
532nm:
- Tattoo removal
- Light ink: red, sky blue and green.
- Treatment of benign vascular lesions
- Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi.
- Treatment of benign pigmented lesions
- Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
Device Description
Nd:YAG laser is a type of solid laser that is stimulated through Yttrium Aluminum Garnet (YAG Crystal) doped with a very small amount of Neodymium (Nd). Nd:YAG laser can generate pulsed or continuous laser, emitting laser with specific wavelength (usually 532nm or 1064nm). The principle of Nd:YAG laser product is that electrons in atoms can absorb energy and change from a lower energy level to higher energy level, then these electrons fall back to the lower energy level, releasing energy in the form of photons. Compared with ordinary light source, laser is monochromatic, directional and brighter.
Q-Switched Nd:YAG Laser is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce two wavelengths, 1064nm and 532nm, to treat different skin color. It consists of control panel module, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired wavelength and the related output energy via control panel.
Machine System
Q-Switched Nd:YAG Laser (hereinafter referred to as "Machine") consists of machine main body (including Laser Device, Transmission and Target Indicating Device, Laser Power Supply and Control System, Safety Protection System, Cooling System, Power Supply System, Control System), 7-Joint Laser Arm, Vari-Focusing Handpiece, Foot Switch, Laser Protective Glasses, Power Cable, Support Bar (A Group of Support Bar and 2 Support Clamps), Casters and Attached Machine Accessories, etc. As shown by Figure 1, the machine shell is ABS shell, its accessories are aluminum alloy parts.
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K Number
K242941Device Name
CO2 Laser Therapy Systems (SHE-LSP003-1)
Manufacturer
Date Cleared
2025-01-27
(124 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Beijing Sano Laser S&T Development Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CO2 Laser Therapy Systems is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery.
Device Description
CO2 Laser Therapy Systems is monochromatic light with strong penetration and precise focusing; When a continuous laser beam with a certain energy irradiates biological tissue, the instantaneous high temperature causes photo induced solidification and photo induced vaporization to irradiated tissue.iradiates biological tissue, the instantane causes photo induced solidification and photo induced vaporization to irradiaed tissue. With modulation pulse mode of CO2 laser, treatment effect can be achieved by control of laser emission frequency. After chosing laser Power, despite the frequency of laser emission, the laser is continuously output at a fixed Interval Time of 1 ms. Changes in frect interval time.
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K Number
K233416Device Name
Cryojet Plus (SHE-ACP001-1)
Manufacturer
Date Cleared
2024-02-06
(119 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Beijing Sano Laser S&T Development Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Cryojet Plus is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
Device Description
Cryojet Plus is composed of main body (including power supply system, cooling system), power cable, supporting arm rod (a group of supporting rod, two support clips), wind tube, adapters, casters and other accessories. Control system consists of LCD screen display and control board, etc; Cooling system includes compressor, evaporator, radiator, fan, water tank; Power supply system is composed of power cable, filter and ON/OFF switch power.
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K Number
K230024Device Name
HI-EMT MAGSHAPE
Manufacturer
Date Cleared
2023-09-06
(245 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Beijing Sano Laser S&T Development Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks, thighs and calves.
- Improvement of muscle tone and firmness, for strengthening muscles in arms.
Device Description
The proposed device is a type of the most advanced electromagnetic noninvasive treatment machine (with attachments). It is used for muscle tension enhancement and muscle strengthening on abdomen, hips, thighs, arms, etc. Three models (SHE-MSP003, SHE-MSP002 and SHE-MSP001) are included in HI-EMT MAGSHAPE series products, and they have the same intended purposes, working theories and specifications.
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K Number
K191970Device Name
Diode Laser Hair Removal System
Manufacturer
Date Cleared
2020-04-06
(257 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Beijing Sano Laser S&T Development Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Diode Laser Hair Removal System 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.
Device Description
The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all Fitzpatrick skin types. There are 4 models included, P-808, P-808L, P-808S and P-808W, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration. The main components of proposed device are Handpiece, Touch screen, Emergency stop switch, Key switch, LED screen, and Foot switch.
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