Manufacturer
Strata Skin Sciences, Inc.MMD Tip
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K181480
- Device name
- MMD Tip
- Company
- Strata Skin Sciences, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-06-05
- Decision date
- 2018-08-01
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The Multi-Micro Dose (MMD) Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the NB-UVB light at delivery in order to calculate and individualize the maximum non-blistering dose for a particular patient.
Intended Use
The Multi-Micro Dose (MMD) Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the NB-UVB light at delivery in order to calculate and individualize the maximum non-blistering dose for a particular patient.
Device Description
The subject device is the Multi-Micro Dose ('MMD') Tip. The MMD Tip filters and reduces the laser output, providing four different dose levels in a single application. The reaction of the target area to the different dose levels assists in determining the patient specific Optimal Therapeutic Dose ('OTD'). The MMD Tip design places four (5mm x 5mm) square filters in the laser aperture.Summary parsed at:2026-06-01 05:57:39 UTC
Predicate devices
1—
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Not ingested
K181480 references 1 predicate/reference device
Cited as predicate
1XTRAC Momentum Excimer Laser System
1 submission cite K181480 as a predicate