Laser Spectrum, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Laser Spectrum, Inc.” (first 1984, latest 1986), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 91 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 |
|---|---|---|---|
| EWQ | Saw, Surgical, Ent (Electric Or Pneumatic) | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| HHR | Laser, Surgical, Gynecologic | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Laser Spectrum, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863520 | CO2 LASER MICROMANIPULATOR | HHR | 1986-10-06 | 26 |
| K844765 | ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN | EWQ | 1985-04-08 | 122 |
| K841781 | MODEL 305AA PORTABLE LASER | GEX | 1984-11-07 | 191 |
| K842498 | DANIELL DBL PUNCTURE LASER LAPAROSCOPY | HET | 1984-09-25 | 91 |
| K841668 | CO2 LAPAROSCOPE | — | 1984-04-23 | 0 |
Recalls
openFDA lists no recalls under a recalling firm named Laser Spectrum, 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.
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 Peripherals, LLC (12 510(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 Spectrum, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Laser Spectrum, Inc.” (first 1984, latest 1986), across 5 product codes in 3 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 Spectrum, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Laser Spectrum, Inc. is 91 days.
Which FDA product codes appear under Laser Spectrum, Inc.?
The most frequent FDA product codes under this applicant name are EWQ (Saw, Surgical, Ent (Electric Or Pneumatic), 1); GEX (Powered Laser Surgical Instrument, 1); HET (Laparoscope, Gynecologic (And Accessories), 1).
Next steps
- See all 5 Laser Spectrum, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EWQ, Laser Spectrum, 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.