Beijing Honkon Technologies Co., Ltd.: FDA filings under this applicant name

FDA lists 5 510(k) clearances under the applicant name “Beijing Honkon Technologies Co., Ltd.” (first 2013, latest 2017), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 216 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

YearClearancesMedian review days
20131116
20143216
20150—
20160—
20171234
20180—
20190—
20200—
20210—
20220—
20230—
20240—
20250—
20260—

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Beijing Honkon Technologies Co., Ltd. took a median 234 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.

Top product codes

Product codeDeviceSubmissions510(k) clearances
GEXPowered Laser Surgical Instrument33
NUVMassager, Vacuum, Light Induced Heating11
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect11

Review panels

Most recent Beijing Honkon Technologies Co., Ltd. 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K161892Slimming Treatment DeviceNUV2017-03-02234
K131838DIODE LASER FOR HIAR REMOVALGEX2014-04-24308
K131837CO2 FRACTIONAL LASERGEX2014-01-22216
K131857Q-SWITCHED ND:YAG LASERGEX2014-01-16206
K131859MULTIFUNCTIONAL SERIESONF2013-10-18116

Recalls

openFDA lists no recalls under a recalling firm named Beijing Honkon Technologies Co., Ltd..

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

Frequently asked questions

How many FDA 510(k) clearances are listed under Beijing Honkon Technologies Co., Ltd.?

FDA lists 5 510(k) clearances under the applicant name “Beijing Honkon Technologies Co., Ltd.” (first 2013, latest 2017), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Beijing Honkon Technologies Co., Ltd.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Beijing Honkon Technologies Co., Ltd. is 216 days.

Which FDA product codes appear under Beijing Honkon Technologies Co., Ltd.?

The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 3); NUV (Massager, Vacuum, Light Induced Heating, 1); ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, 1).

Next steps

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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