Last synced on 27 June 2025 at 11:06 pm

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.

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231613
510(k) Type
Traditional
Applicant
Zhuzhou Goldenhot Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
7/31/2023
Days to Decision
59 days
Submission Type
Summary

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.

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231613
510(k) Type
Traditional
Applicant
Zhuzhou Goldenhot Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
7/31/2023
Days to Decision
59 days
Submission Type
Summary