Sun Pharmaceutical Industries, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Sun Pharmaceutical Industries, Inc.” (first 2024, latest 2024), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 30 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
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 30 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sun Pharmaceutical Industries, Inc. took a median 30 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 code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| MVF | System, Laser, Photodynamic Therapy | 1 | 0 |
Review panels
Most recent Sun Pharmaceutical Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241358 | BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E | GEX | 2024-06-13 | 30 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P990019 | PMA | BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR | 1999-12-03 |
Recalls
openFDA lists no recalls under a recalling firm named Sun Pharmaceutical Industries, 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.
Device clinical trials
An industry sponsor named Sun Pharmaceutical Industries, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07144852: Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities (Recruiting, started 2025-11-29)
- NCT07144345: Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp (Recruiting, started 2025-11-19)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sun Pharmaceutical Industries, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Sun Pharmaceutical Industries, Inc.” (first 2024, latest 2024), plus 1 PMA decision, across 2 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 Sun Pharmaceutical Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sun Pharmaceutical Industries, Inc. is 30 days.
Which FDA product codes appear under Sun Pharmaceutical Industries, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 1); MVF (System, Laser, Photodynamic Therapy, 1).
Next steps
- See all 1 Sun Pharmaceutical Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Sun Pharmaceutical Industries, 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.