510(k) K855146
- Device
- LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL
- Applicant
- LASERSCOPE
- 510(k) number
- K855146
- Product code
- LMS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-04-11
- Date received
- 1985-12-24
- Regulation
- 874.4490
- Classification name
- Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROSS ERICKSON
- Address
- 3350 Scott Blvd., Bldg.30 Santa Clara CA US 95051 95051
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LMS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K871424 | ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER | Hgm, Inc. | 1987-07-08 |
Legacy Summary#
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FDA Review#
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