Product areas
FDA product code distribution
Zhuzhou Goldenhot Medical Technology Co., Ltd.
Country / region:China (CN)
510(k) submissions
2
Filtered: OHT
Latest clearance
2024-12-21
Product codes
1
OHT
510(k) submissions
2 total · filtered by OHT
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K243085 | IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) | OHT | Class 2 | 2024-12-21 |
| K231613 | 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. | OHT | Class 2 | 2023-07-31 |
Company profile
- Canonical name
- Zhuzhou Goldenhot Medical Technology Co., Ltd.
- Country
- China(CN)
- Address
- Rm. 301, Plant C-3, Phase 5, Xinma Power Innovation Park, # 889, Xianyue Huan Rd., Majiahe St.,Tianyuan District Zhuzhou, CN 412000
Cited predicates
4- K230739
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
- K231613
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.
- K220669
IPL HAIR REMOVAL HANDSET, Model: IPL-666
- K223928
Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
Zhuzhou Goldenhot Medical Technology Co., Ltd. references 4 predicate/reference devices
Cited as predicate
3- K243085
IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)
- K241120
Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)
- K232575
Hair Removal Device, Model(s): R2815-G Pro, R2815-G
3 submissions cite Zhuzhou Goldenhot Medical Technology Co., Ltd. as a predicate