Surgical Laser Technologies, Inc.: FDA filings under this applicant name
FDA lists 51 510(k) clearances under the applicant name “Surgical Laser Technologies, Inc.” (first 1985, latest 2004), across 10 product codes in 7 review panels. Median 510(k) review time under this name: 82 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 | 35 | 35 |
| LNK | Laser For Gastro-Urology Use | 3 | 3 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 2 | 2 |
| HHR | Laser, Surgical, Gynecologic | 2 | 2 |
| HQB | Photocoagulator And Accessories | 2 | 2 |
| HQF | Laser, Ophthalmic | 2 | 2 |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | 2 | 2 |
| FJL | Resectoscope | 1 | 1 |
| GAZ | Tubing, Noninvasive | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
- General and Plastic Surgery (36)
- Gastroenterology and Urology (4)
- Ophthalmic (4)
- Anesthesiology (2)
- Ear, Nose and Throat (2)
- Obstetrics and Gynecology (2)
- General Hospital (1)
Most recent Surgical Laser Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042211 | MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS | GEX | 2004-11-08 | 84 |
| K023624 | SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921 | GEX | 2003-01-27 | 90 |
| K011409 | SLT LASERPRO CTH HOLMIUM LASER SYSTEM | GEX | 2001-06-14 | 37 |
| K010041 | SLT DIFFUSER FIBER | GEX | 2001-03-07 | 61 |
| K984018 | HEMOSLEEVE, MODEL 4.0MM, 5.5MM | GEI | 1999-03-15 | 123 |
| K983050 | PNEUMATIC CUTTER SYSTEM | ERL | 1998-11-25 | 85 |
| K981041 | SLT BIPOLAR SHEATH | ERL | 1998-08-27 | 160 |
| K972548 | SLT CL MD CONTACT LASER SYSTEM | GEX | 1998-04-21 | 287 |
| K980156 | SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS | GEX | 1998-02-27 | 42 |
| K960821 | SLT FUMICH PROBE GUIDE | GEX | 1996-05-16 | 77 |
41 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Surgical Laser Technologies, 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.
- Surgical Specialties Corp (33 510(k)s)
- Surgical Technologies, Inc. (28 510(k)s)
- Surgical Navigation Technologies, Inc. (27 510(k)s)
- Surgical Instrument Service and Savings, Inc. (23 510(k)s)
- Surgical Dynamics, Inc. (12 510(k)s)
- Surgical Technology Laboratories, Inc. (12 510(k)s)
- Surgical Appliance Industries, Inc. (9 510(k)s)
- Surgical Instruments Service and Savings, Inc. (8 510(k)s)
- Surgical Theater, Inc. (8 510(k)s)
- Surgical Information Sciences, Inc. (7 510(k)s)
- Surgical Innovations Plc (7 510(k)s)
- Surgical Specialties Corp. Dba Angiotech (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgical Laser Technologies, Inc.?
FDA lists 51 510(k) clearances under the applicant name “Surgical Laser Technologies, Inc.” (first 1985, latest 2004), across 10 product codes in 7 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 Surgical Laser Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgical Laser Technologies, Inc. is 82 days.
Which FDA product codes appear under Surgical Laser Technologies, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 35); LNK (Laser For Gastro-Urology Use, 3); ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, 2).
Next steps
- See all 51 Surgical Laser Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Surgical Laser Technologies, 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.