Device Information

The DermRays Revive uses a diode laser with an output wavelength of 1064nm, which targets tissues like melanin and hemoglobin without damaging the skin. It features a pulse width of 400ms and energy density ranging from 5.0 to 10.0 J/cm², delivered through a 15mm handpiece. The device operates on AC100-240V, 50/60Hz, and is intended for professional use under prescription.

Indications

DermRays Revive is designed to remove hair and reduce permanent hair. It is also intended for wrinkle treatment. Permanent hair reduction refers to a long-term, stable reduction in hair regrowth, typically measured at 6, 9, and 12 months after completing a treatment regime. It can be used on all skin types, including tanned skin.

Intended Use

DermRays Revive is intended for permanent hair reduction and wrinkle treatment. It is designed for all skin types (Fitzpatrick types I-VI), including tanned skin. This device is for professional use in appropriate settings.

Availability

Prescription use only.

Contraindications

The 510k document does not specify contraindications.

Limitations

The device is limited to use by professionals trained in laser procedures and should only be used for the approved indications.

Study Results

No clinical testing has been performed, but bench and laboratory testing demonstrated the device’s performance and safety. Testing covered electrical safety, biocompatibility, and software validation, showing that the device meets required standards.

Regulatory Information

• Regulation Number: 21 CFR 878.4810
• Regulatory Class: Class II
• Product Code: GEX
• 510(k) Number: K231910
• The device meets FDA regulations, including biocompatibility testing (ISO 10993), electrical safety, and software validation.
• Manufacturer compliance with 21 CFR Part 820 Quality System regulations is required.

Manufacturer Information

• Name: Wuhan Lotuxs Technology Co., Ltd.
• Address: 501/E2, No. 999 High-tech Avenue, Wuhan, Hubei 430206, China
• Contact: Na Wu, Quality Manager

Predicate Device Information

• Primary predicate device: K141425 Cynosure Elite+ Laser
• Secondary predicate device: K232117 Diode Laser Hair Removal
• Is the Predicate Device an Earlier Version of the Same Device?: No
• Differences: The predicate device treats additional conditions like vascular lesions and pigmented lesions, while DermRays Revive focuses on hair removal and wrinkle treatment. DermRays Revive uses similar laser technology, but slight differences in laser characteristics exist.

Implications

The device offers a safe, effective method for hair removal and wrinkle treatment, expanding options for cosmetic procedures.

References

1. DermRays Revive. 510(k) Number: K231910. FDA Summary Link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K231910
2. http://www.lotuxs.com
3. https://lotuxs.en.alibaba.com/