510(k) K881459
- Device
- NANOLAS ND:YAG OPHTHALMIC LASER
- Applicant
- BIOPHYSIC MEDICAL, INC.
- 510(k) number
- K881459
- Product code
- LOI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-04-13
- Date received
- 1988-04-06
- Regulation
- 510(k) Premarket Notification
- Classification name
- Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Ophthalmic
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DOUGLAS DONALDSON
- Address
- 2440 Estand Way Pleasant Hill CA US 94523 94523
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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