Laser Media: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Laser Media” (first 1985, latest 1987), plus 1 PMA decision, across 4 product codes in 4 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| LNK | Laser For Gastro-Urology Use | 8 | 8 |
| HHR | Laser, Surgical, Gynecologic | 2 | 2 |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | 2 | 2 |
| LOI | Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary | 1 | 0 |
Review panels
Most recent Laser Media 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K872352 | FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA | HHR | 1987-12-30 | 196 |
| K872351 | FIBERLASE II ND:YAG LASER FOR PULMONARY USE | LLO | 1987-12-11 | 177 |
| K872350 | FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE | LNK | 1987-08-10 | 54 |
| K872031 | UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM | LNK | 1987-08-04 | 70 |
| K863428 | SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG | LNK | 1986-12-03 | 90 |
| K863583 | CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER | LNK | 1986-11-24 | 76 |
| K862444 | FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA | HHR | 1986-09-25 | 91 |
| K860063 | ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM | LNK | 1986-02-05 | 30 |
| K855197 | FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM | LNK | 1986-01-21 | 26 |
| K852798 | FIBERLASE 100 MEDICAL LASER SYSTEM | LNK | 1985-07-29 | 28 |
2 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P850019 | PMA | PHOTOTOME(TM) SYSTEM 2700 | 1985-08-08 |
Recalls
openFDA lists no recalls under a recalling firm named Laser Media.
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 Peripherals, LLC (12 510(k)s)
- Laser Spectrum, Inc. (5 510(k)s)
- Laser Max Medical Technologies Corp. (4 510(k)s)
- Laser Optik Systeme GmbH & Co. KG (3 510(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 Media?
FDA lists 12 510(k) clearances under the applicant name “Laser Media” (first 1985, latest 1987), plus 1 PMA decision, 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 Media?
The median time from FDA receipt to decision across 510(k)s cleared under the name Laser Media is 64 days.
Which FDA product codes appear under Laser Media?
The most frequent FDA product codes under this applicant name are LNK (Laser For Gastro-Urology Use, 8); HHR (Laser, Surgical, Gynecologic, 2); LLO (Laser, Neodymium:Yag, Pulmonary Surgery, 2).
Next steps
- See all 12 Laser Media clearances with predicates and recalls
- Run predicate analysis for product code LNK, Laser Media'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.