Candela Laser Corp.: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Candela Laser Corp.” (first 1988, latest 1996), across 16 product codes in 6 review panels. Median 510(k) review time under this name: 96 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 |
|---|---|---|
| 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 | 21 | 21 |
| GEH | Unit, Cryosurgical, Accessories | 3 | 3 |
| ODF | Mini Endoscope, Gastroenterology-Urology | 3 | 3 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| FFK | Lithotriptor, Electro-Hydraulic | 2 | 2 |
| HQF | Laser, Ophthalmic | 2 | 2 |
| FBX | Sound, Urethral, Metal Or Plastic | 1 | 1 |
| FDE | Laparoscopy Kit | 1 | 1 |
| FEB | Accessories, Cleaning, For Endoscope | 1 | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 1 | 1 |
Plus 6 more product codes.
Review panels
- General and Plastic Surgery (24)
- Gastroenterology and Urology (12)
- Ophthalmic (3)
- Cardiovascular (2)
- General Hospital (1)
- Physical Medicine (1)
Most recent Candela Laser Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951033 | ANDELA DYNAMIC COOLING DEVICE | IMD | 1996-08-15 | 528 |
| K955662 | CANDELA Q-SWITCHED ALEXANDRITE LASERS | GEX | 1996-06-14 | 185 |
| K955011 | CANDELA HCS 2000 URETHERAL WARMER CATHETER | GEH | 1996-04-03 | 154 |
| K954872 | CANDELA CRYO-PROBE HOLDER | GEH | 1996-02-05 | 104 |
| K954934 | CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE | GEX | 1996-02-02 | 98 |
| K953412 | CANDELA MODEL PLTL-1 LASER SYSTEM | GEX | 1995-10-24 | 96 |
| K953294 | CANDELA CRYOSYSTEM CS-5 | GEH | 1995-10-18 | 96 |
| K950831 | ALEXLAZR | GEX | 1995-05-26 | 91 |
| K946386 | CANDELA RUBY LAZE Q-SWITCHED RUBY LASER | GEX | 1995-03-24 | 93 |
| K950661 | CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE | GEX | 1995-03-10 | 25 |
33 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2007-01-15.
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.
- Candela Corp. (56 510(k)s)
- Candela Corpation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Candela Laser Corp.?
FDA lists 43 510(k) clearances under the applicant name “Candela Laser Corp.” (first 1988, latest 1996), across 16 product codes in 6 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 Candela Laser Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Candela Laser Corp. is 96 days.
Which FDA product codes appear under Candela Laser Corp.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 21); GEH (Unit, Cryosurgical, Accessories, 3); ODF (Mini Endoscope, Gastroenterology-Urology, 3).
Next steps
- See all 43 Candela Laser Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Candela Laser Corp.'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.