Hand-Held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
by Shenzhen Chuangtong Yigou Technology Co., Ltd.
510(k) K251000
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK251000 | Date30 Jun 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OHT
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Light-Based Over-the-Counter Hair Removal Device, classified as a Class II medical product. It employs light technology to selectively target and remove unwanted hair through controlled energy delivery, suitable for cosmetic hair reduction in various body areas. The device operates as a non-invasive alternative to traditional hair removal methods, targeting hair follicles to inhibit regrowth.
The Hand-Held Hair Removal Device is designed for single-use per session and is intended for use in non-clinical settings, such as home or professional spa environments. Each model (FZ-200A, FZ-201, FZ-202, CT05–CT09) features a dedicated light exit for targeted application on areas like the upper lip, underarms, legs, or bikini region. Supplied as a non-sterile, reusable device (per manufacturer specifications), it adheres to FDA 510(k) clearance (K251000) under regulation 21 CFR 878.4810 and is classified under Product Code OHT. No MRI safety restrictions are specified.
Other devices from Shenzhen Chuangtong Yigou Technology Co., Ltd.
Questions
AI-generated answers, 19 Sep 2026
How is the Hand-Held Hair Removal Device intended to be used in different settings like home or professional spas?
The device is designed for non-clinical use, meaning it can be safely operated in home settings or professional spa environments. Each model (FZ-200A, FZ-201, FZ-202, CT05–CT09) is tailored for targeted hair reduction on specific areas like the upper lip, underarms, legs, or bikini region. Since it is reusable and non-sterile, it is not intended for clinical or surgical environments where sterile conditions are required.
Are the different models (FZ-200A, FZ-201, FZ-202, CT05–CT09) interchangeable, or do they have specific applications?
The models are not interchangeable—they are designed with dedicated light exits for targeted application on specific body areas. For example, the FZ-200A, FZ-201, and FZ-202 may be optimized for smaller regions like the upper lip or underarms, while the CT05–CT09 models likely cater to larger areas such as legs or bikini regions. Always refer to the manufacturer’s instructions for proper model selection based on the treatment area.
Is the Hand-Held Hair Removal Device reusable, and if so, how should it be maintained?
Yes, the device is classified as reusable per manufacturer specifications, though it is non-sterile. Since it is intended for cosmetic hair reduction in non-clinical settings, proper maintenance involves cleaning between uses to remove hair and debris. The manufacturer’s guidelines should be followed to ensure longevity and safe operation, though no specific sterilization process is required.
What regulatory pathway was followed for FDA clearance, and what does the Product Code OHT indicate?
The device received FDA clearance through a 510(k) Traditional Review under the classification 21 CFR 878.4810, with a Substantially Equivalent (SE) determination. The Product Code OHT (Over-the-Counter Hair Removal) categorizes it as a non-prescription, cosmetic hair reduction device, confirming its intended use for non-clinical settings like home or spa environments.
Can this device be used on all body areas, or are there specific regions it is optimized for?
The device is designed for targeted cosmetic hair reduction on specific body areas, such as the upper lip, underarms, legs, or bikini region. Each model (FZ-200A, FZ-201, FZ-202, CT05–CT09) features a dedicated light exit optimized for these areas. While it is versatile for common cosmetic treatment zones, it is not intended for medical or surgical hair removal procedures.