Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
510(k) K243030
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK243030 | Date25 Oct 2024 | 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- Withdrawn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
The Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) is a light-based over-the-counter hair removal device designed for the removal of unwanted body and facial hair. It operates as a non-invasive method to target hair follicles, promoting long-term hair reduction through controlled laser energy.
This device is intended for home use and is classified as a Class 2 medical device under FDA regulation 878.4810. Supplied as a single-use or reusable system depending on the model variant, it requires no surgical setting or professional administration. The device has received FDA 510(k) clearance under the Special 510(k) program, with a determination of Substantially Equivalent to predicate devices, and is authorized for distribution in the United States.
Other devices from Ulike Co., Ltd.
Questions
AI-generated answers, 19 Sep 2026
What types of hair can the Diamond Air+ device effectively target for removal, and is it suitable for all skin tones?
The Diamond Air+ is designed for non-invasive removal of unwanted body and facial hair through controlled laser energy targeting hair follicles. While it is intended for home use on various areas, its effectiveness depends on hair color (typically best for dark hair) and skin tone. The device is not explicitly stated to be suitable for all skin tones, so users with lighter hair or darker skin should consult the included instructions for guidance on optimal results.
Are the Diamond Air+ models single-use or reusable, and how does this impact their maintenance?
The Diamond Air+ comes in multiple model variants (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W), some of which are supplied as single-use while others are reusable. Single-use models are intended for one-time use and disposal, while reusable models require cleaning and maintenance as per manufacturer guidelines. Always refer to the specific model’s instructions for proper care to ensure safety and longevity.
How should the Diamond Air+ device be stored to maintain its performance and safety?
The Diamond Air+ should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, and moisture to preserve its functionality. If reusable, ensure it is fully charged and stored in its original packaging or a designated case to prevent damage. Always follow the manufacturer’s storage instructions provided in the user manual.
What regulatory pathway was followed for FDA clearance of the Diamond Air+ device?
The Diamond Air+ received FDA 510(k) clearance under the Special 510(k) program, with a determination of Substantially Equivalent to predicate devices. This means the FDA reviewed it against existing, legally marketed devices and concluded it poses the same risk profile. The clearance was granted on October 25, 2024, and the device is authorized for distribution in the United States under Class 2 medical device regulations (21 CFR 878.4810).