510(k) Report

FDA applicant

Shenzhen Semlamp Intelligent Technology Co., Ltd.

Shenzhen, CN3 decisions2022–20260 recalls

FDA records 3 decisions for Shenzhen Semlamp Intelligent Technology Co., Ltd. (Shenzhen, CN) from 2022 to 2026: 3 510(k) clearances. All are in product code OHT (Light Based Over-The-Counter Hair Removal). Since 2016 its 510(k)s took a median of 63 days from receipt to decision, against 70 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Shenzhen Semlamp Intelligent Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 12024: 12026 (partial year): 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Shenzhen Semlamp Intelligent Technology Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OHTLight Based Over-The-Counter Hair Removal3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 63 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 70 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K260518IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352…Shenzhen Semlamp Intelligent Technology Co., Ltd. · 2026
  • K240969IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)Shenzhen Semlamp Intelligent Technology Co., Ltd. · 2024
  • K221246IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)Shenzhen Semlamp Intelligent Technology Co., Ltd. · 2022

All 3 as Shenzhen Semlamp Intelligent Technology Co., Ltd. →