← Product Code [GGX](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GGX) · K902263

# OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION (K902263)

_Trimedyne, Inc. · GGX · Jul 23, 1990 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GGX/K902263

## Device Facts

- **Applicant:** Trimedyne, Inc.
- **Product Code:** [GGX](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GGX.md)
- **Decision Date:** Jul 23, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.6160
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GGX/K902263](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GGX/K902263)

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