Multilite Dye Handpieces — Class II medical device recall Z-1599-2013
Terminated recall by ConBio, a CynoSure Company, reported 2013-07-03, distributed nationwide. An inconsistency was identified related to electronic display identification of the optional Multilite Dye Han
| Recall number | Z-1599-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConBio, a CynoSure Company, Fremont, CA, United States |
| Recall initiated | 2013-05-09 |
| Classified | 2013-06-26 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2013-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CL |
| Model numbers | 650, 659-1100 |
Product
Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. Manufactured by: ConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538
Reason for recall
An inconsistency was identified related to electronic display identification of the optional Multilite Dye Handpieces of the RevLite SI Laser system that may confuse user.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1599-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.