510(k) K871876
- Device
- MODEL 5050 SURGILASER FOR PULMONARY USE
- Applicant
- LASERMATIC, INC.
- 510(k) number
- K871876
- Product code
- LLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-01-22
- Date received
- 1987-05-14
- Regulation
- 874.4500
- Classification name
- Laser, Neodymium:yag, Pulmonary Surgery
- Medical specialty
- Ear Nose & Throat
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONALD F HULTS
- Address
- P.O. Box 7848 Dallas TX US 75209 75209
FDA Registration Numbers#
- 3011137372
- 9611102
- 3003761012
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LLO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K884815 | SLT CLMD CONTACT LASER | Surgical Laser Technologies, Inc. | 1988-12-22 |
| K881499 | SURGILASE YAG 100 FOR GYNECOLOGY USE | Surgilase, Inc. | 1988-04-29 |
| K880592 | LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE | Laser Peripherals, LLC | 1988-04-25 |
| K880170 | MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS | Cooper Lasersonics, Inc. | 1988-03-24 |
| K874254 | ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS | Minnesota Laser Corp. | 1988-03-04 |
| K875104 | SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE | Laserguide | 1988-02-02 |
| K872351 | FIBERLASE II ND:YAG LASER FOR PULMONARY USE | Laser Media | 1987-12-11 |
| K870505 | OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL | Trimedyne, Inc. | 1987-08-07 |
| K871511 | SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS | Medical Energy, Inc. | 1987-07-21 |
| K862698 | 6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION | Cooper Lasersonics, Inc. | 1986-08-05 |
| K861921 | LASER BRONCHOSCOPE SYSTEM | Pilling Co. | 1986-06-02 |
| K861583 | CO2 LASER BRONCHOSCOPE SYSTEM | Richard Wolf Medical Instruments Corp. | 1986-05-21 |
| K861045 | MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT | Sharplan Industries, Inc. | 1986-04-23 |
| K855095 | S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA | Surgical Laser Technologies, Inc. | 1986-02-18 |
| K852761 | CILAS MODEL YM101 | Inframed, Inc. | 1985-11-14 |
Legacy Summary#
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FDA Review#
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