510(k) K853902
- Device
- ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY
- Applicant
- ENDO LASE, INC.
- 510(k) number
- K853902
- Product code
- EWG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-01-09
- Date received
- 1985-09-20
- Regulation
- 874.4500
- Classification name
- Laser, Ent Microsurgical Carbon-dioxide
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JONATHAN S KAHAN
- Address
- Attn: Jonathan S. Kahan 815 Connecticut Ave. Washington DC US 20006 20006
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EWG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K924652 | BENSON CCA100 | Benson Medical Instruments Co. | 1993-04-09 |
| K870587 | LASERMATIC SURGILASER MODEL 5050 | Lasermatic OY | 1988-08-10 |
| K880429 | ILLUMINA 55 CO2 LASER SYSTEM | Cooper Lasersonics, Inc. | 1988-04-18 |
| K880428 | ILLUMINA 25 CO2 LASER SYSTEM | Cooper Lasersonics, Inc. | 1988-04-18 |
| K880427 | ILLUMINA 40 CO2 LASER SYSTEM | Cooper Lasersonics, Inc. | 1988-04-18 |
| K872710 | MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT | Directed Energy, Inc. | 1987-09-24 |
| K870840 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH | Directed Energy, Inc. | 1987-06-12 |
| K864975 | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT) | Laserscope | 1987-02-25 |
| K862866 | MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE | Directed Energy, Inc. | 1987-01-09 |
| K862865 | MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE | Directed Energy, Inc. | 1987-01-09 |
| K862150 | MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) | Directed Energy, Inc. | 1986-09-04 |
| K862005 | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER | Laserscope | 1986-08-29 |
| K860975 | MODEL 545-45 LASER FOR EAR, NOSE & THROAT | Britt Corp., Inc. | 1986-07-18 |
| K860277 | MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT | Britt Corp., Inc. | 1986-05-06 |
| K854471 | PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T | Minnesota Laser Corp. | 1986-02-13 |
Legacy Summary#
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FDA Review#
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