Optilase Model 1000 Nd:Yag Laser Add'L Indication
FDA 510(k) K902263 · Trimedyne, Inc.
510(k) numberK902263
Submission
- Device name
- Optilase Model 1000 Nd:Yag Laser Add'L Indication
- Applicant
- Trimedyne, Inc.
Tustin, CA, US - Received
- May 21, 1990
- Decision date
- July 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGX – Pipette, Sahli
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.6160
- Specialty
- Hematology
Other 510(k)s with product code GGX
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|---|---|---|---|
| K894389 | Creatinine for Manual or Automated ApplicationsGGX · Traditional | Catachem, Inc. | 10/12/1989SE |
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Questions and answers
When was Optilase Model 1000 Nd:Yag Laser Add'L Indication cleared by the FDA?
Optilase Model 1000 Nd:Yag Laser Add'L Indication (K902263) received a 510(k) decision of Substantially Equivalent on July 23, 1990, 63 days after the submission was received.
What is the product code of K902263?
The FDA product code is GGX – Pipette, Sahli, a Class I (low risk) device regulated under 21 CFR 864.6160.