Laser Peripherals, LLC: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Laser Peripherals, LLC” (first 1988, latest 2017), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 72 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 | 1 | 122 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Laser Peripherals, LLC took a median 122 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 | 9 | 9 |
| FCS | Light, Catheter, Fiberoptic, Glass, Ureteral | 1 | 1 |
| HHR | Laser, Surgical, Gynecologic | 1 | 1 |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | 1 | 1 |
Review panels
- General and Plastic Surgery (9)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Laser Peripherals, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers | GEX | 2017-06-08 | 122 |
| K030959 | BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 | GEX | 2003-04-25 | 29 |
| K011207 | LASER PERIPHERALS REUSABLE HOLMIUM FIBER | GEX | 2001-07-24 | 96 |
| K992083 | SCATTERFREE LATERAL EMITTING FIBER | GEX | 1999-07-12 | 21 |
| K974229 | LS-905 FIBERCHOICE ADAPTER SYSTEM | GEX | 1998-02-10 | 90 |
| K972272 | LASER PERIPHERALS HOLMIUM BARE FIBERS | GEX | 1997-07-29 | 41 |
| K961516 | LASER PERIPHERALS INC. BARE FIBER | GEX | 1996-06-27 | 66 |
| K961079 | LASER PERIPHERALS INC. SCATTERFREE FIBER | GEX | 1996-05-22 | 65 |
| K901786 | LASEGUIDE CAT # CLF-600D & CLF-1000D | GEX | 1990-06-27 | 70 |
| K880591 | LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE | HHR | 1988-06-01 | 111 |
2 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-06-20.
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.
- Laser Industries , Ltd. (20 510(k)s)
- Laser Engineering, Inc. (18 510(k)s)
- Laser Photonics, Inc. (14 510(k)s)
- Laser Media (12 510(k)s)
- Laser-Optik-Systeme GmbH & Co. KG (7 510(k)s)
- Laser Spectrum, Inc. (5 510(k)s)
- Laser Max Medical Technologies Corp. (4 510(k)s)
- Laser Surgical Systems (3 510(k)s)
- Laser Associated Sciences, Inc. (2 510(k)s)
- Laser Center Dev. Corp. (2 510(k)s)
- Laser Dental Innovations (2 510(k)s)
- Laser Endo Technic (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Laser Peripherals, LLC?
FDA lists 12 510(k) clearances under the applicant name “Laser Peripherals, LLC” (first 1988, latest 2017), across 4 product codes in 4 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 Laser Peripherals, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Laser Peripherals, LLC is 72 days.
Which FDA product codes appear under Laser Peripherals, LLC?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 9); FCS (Light, Catheter, Fiberoptic, Glass, Ureteral, 1); HHR (Laser, Surgical, Gynecologic, 1).
Next steps
- See all 12 Laser Peripherals, LLC clearances with predicates and recalls
- Run predicate analysis for product code GEX, Laser Peripherals, LLC'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.