FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.
K Number: K231613
·
Decision Jul 31, 2023
Classifications
1
FEI Numbers
90
Registration Numbers
91
Same Product Code
161
Applicant Total
3
Review Days
59
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Basic Information
- Device Name
- Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.
- K Number
- K231613
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zhuzhou Goldenhot Medical Technology Co., Ltd.
- Date Received
- June 2, 2023
- Decision Date
- July 31, 2023
- Product Code
- OHT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OHT | Light Based Over-The-Counter Hair Removal | FDA class 2 | General, Plastic Surgery |
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