Sunrise Technologies, Inc.: FDA clearances and approvals
Sunrise Technologies, Inc. has 18 FDA 510(k) clearances (first 1990, latest 1996), plus 1 PMA decision, across 5 product codes in 4 review panels. Median 510(k) review time: 90 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 15 | 15 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| KOJ | Airbrush | 1 | 1 |
| LOI | Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary | 1 | 0 |
Review panels
- General and Plastic Surgery (15)
- Dental (2)
- General Hospital (1)
- Ophthalmic (1)
Most recent Sunrise Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962192 | SUNRISE CURING LAMP | EBF | 1996-09-03 | 88 |
| K942542 | SLASE 210 PLUS HOLMIUM LASER SYSTEM | GEX | 1994-09-01 | 97 |
| K932997 | MICROPREP CAVITY PREPERATION SYSTEM | KOJ | 1994-04-25 | 311 |
| K933007 | SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMS | GEX | 1994-01-10 | 203 |
| K933017 | MODEL 5030 SUCTION HANDPIECE SYSTEM | GEX | 1993-07-26 | 35 |
| K931774 | UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER | GEX | 1993-07-22 | 104 |
| K930879 | 2.5 WATT PULSED DENTAL LASER SYSTEM | GEX | 1993-05-21 | 91 |
| K930789 | 8-WATT PULSED DENTAL LASER SYSTEM | GEX | 1993-05-21 | 94 |
| K925549 | SLASE 210 PLUS HOLMIUM LASER SYSTEM | GEX | 1993-03-09 | 126 |
| K920248 | MODEL SLASE 210 HOLMIUM LASER SYSTEM | GCX | 1992-07-21 | 182 |
8 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P990078 | PMA | HYPERION LTK SYSTEM | 2000-06-30 |
Recalls
openFDA lists no recalls under a recalling firm named Sunrise Technologies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Sunrise Technologies, Inc. have?
Sunrise Technologies, Inc. has 18 FDA 510(k) clearances (first 1990, latest 1996), plus 1 PMA decision, across 5 product codes in 4 review panels.
How long does FDA take to clear Sunrise Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sunrise Technologies, Inc.'s cleared 510(k)s is 90 days.
What devices does Sunrise Technologies, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 15); EBF (Material, Tooth Shade, Resin, 1); GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered, 1).
Has Sunrise Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sunrise Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 18 Sunrise Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Sunrise Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.