Beijing Adss Development Co., Ltd.: FDA filings under this applicant name

FDA lists 10 510(k) clearances under the applicant name “Beijing Adss Development Co., Ltd.” (first 2016, latest 2024), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 180 days. Since 2017 the median was 204 days, against 94 days for all cleared 510(k)s in the same product codes. 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
2016387
20171224
20180—
20190—
20201252
20210—
20221204
2023160
20243192
20250—
20260—

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Beijing Adss Development Co., Ltd. took a median 204 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.

Top product codes

Product codeDeviceSubmissions510(k) clearances
GEXPowered Laser Surgical Instrument66
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect22
NGXStimulator, Muscle, Powered, For Muscle Conditioning11
OLPOver-The-Counter Powered Light Based Laser For Acne11

Review panels

Most recent Beijing Adss Development Co., Ltd. 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)GEX2024-12-20192
K233307Intensity Pulsed Light Therapy SystemONF2024-03-15168
K231896Diode Laser Therapy SystemGEX2024-02-20237
K231318Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)NGX2023-07-0760
K220268Picosecond Laser System (Model PS10-A and PS10-B)GEX2022-08-23204
K192295PDT-FACEOLP2020-05-01252
K161926ND YAG Q-switch Laser Therapy MachineGEX2017-02-22224
K161692Diode Laser Therapy MachineGEX2016-11-16149
K161925CO2 Laser Therapy MachineGEX2016-10-0584
K161286IPL Therapy MachineONF2016-08-0487

Recalls

openFDA lists no recalls under a recalling firm named Beijing Adss Development 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 Adss Development Co., Ltd.?

FDA lists 10 510(k) clearances under the applicant name “Beijing Adss Development Co., Ltd.” (first 2016, latest 2024), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

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

The median time from FDA receipt to decision across 510(k)s cleared under the name Beijing Adss Development Co., Ltd. is 180 days. Since 2017: 204 days, versus 94 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Beijing Adss Development Co., Ltd.?

The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 6); ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, 2); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 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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