Guangdong Optomedic Technologies, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Guangdong Optomedic Technologies, Inc.” (first 2023, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 134 days. Since 2017 the median was 134 days, against 91 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
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 5 | 152 |
| 2024 | 2 | 65 |
| 2025 | 1 | 63 |
| 2026 | 1 | 265 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Guangdong Optomedic Technologies, Inc. took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 6 | 6 |
| HIF | Insufflator, Laparoscopic | 2 | 2 |
| OWN | Confocal Optical Imaging | 1 | 1 |
Review panels
Most recent Guangdong Optomedic Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252318 | Insufflator (OPTO-IFL1000) | HIF | 2026-04-16 | 265 |
| K252697 | 3D Laparoscope | GCJ | 2025-10-29 | 63 |
| K242513 | FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) | GCJ | 2024-10-23 | 61 |
| K241530 | Stellar Imaging System | GCJ | 2024-08-07 | 69 |
| K231342 | Insufflator (OPTO-IFL1000) | HIF | 2023-09-20 | 134 |
| K230407 | FloNavi Open Field Fluorescence Imaging System | OWN | 2023-07-17 | 152 |
| K231003 | Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) | GCJ | 2023-07-06 | 90 |
| K221861 | FloNavi Endoscopic Fluorescence Imaging System | GCJ | 2023-02-18 | 236 |
| K221781 | Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH | GCJ | 2023-02-02 | 226 |
Recalls
openFDA lists no recalls under a recalling firm named Guangdong Optomedic Technologies, Inc..
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.
- Guangdong Biolight Meditech Co., Ltd. (21 510(k)s)
- Guangdong Transtek Medical Electronics Co., Ltd. (17 510(k)s)
- Guangdong Kingfa Sci. & Tech.Co., Ltd. (14 510(k)s)
- Guangdong Horigen Mother & Baby Products Co., Ltd. (7 510(k)s)
- Guangdong Genial Technology Co., Ltd. (5 510(k)s)
- Guangdong Newdermo Biotech Co., Ltd. (5 510(k)s)
- Guangdong Jinme Medical Technology Co., Ltd. (4 510(k)s)
- Guangdong Prestige Technology Co., Ltd. (4 510(k)s)
- Guangdong Youmeng Electrical Technology Co., Ltd. (4 510(k)s)
- Guangdong Gymda Medical Technology Co.,Ltd (2 510(k)s)
- Guangdong Kaiyang Medical Technology Co., Ltd. (2 510(k)s)
- Guangdong Xinyu Electronic and Technology Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Guangdong Optomedic Technologies, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Guangdong Optomedic Technologies, Inc.” (first 2023, latest 2026), across 3 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 Guangdong Optomedic Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guangdong Optomedic Technologies, Inc. is 134 days. Since 2017: 134 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Guangdong Optomedic Technologies, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 6); HIF (Insufflator, Laparoscopic, 2); OWN (Confocal Optical Imaging, 1).
Next steps
- See all 9 Guangdong Optomedic Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Guangdong Optomedic Technologies, Inc.'s most frequent
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.