Safety and Efficacy of a 2,910 nm Fractional Ablative Fiber Laser (UltraClear®) for Improvements of Skin Laxity and Lifting of the Lower Face, Submental, and Neck Treatment Areas (UC 29-2026)

Inclusion Criteria:

1. Fitzpatrick skin types I-III participants with Fitzpatrick Skin Types IV-VI may be enrolled only at the investigator's discretion, based on individualized risk assessment documenting skin tone-related risk of post-inflammatory hyperpigmentation, wound healing history, and prior response to ablative or energy-based treatments. Risk assessment documentation must be retained in the participant's study file. Male or female.
2. Participants must be between 35 and 65 years of age.
3. Participants must have the ability to receive two lower face and full neck resurfacing laser treatments with desire for improvement in lifting and skin laxity.
4. Participants must read, understand, and sign the Informed Consent Form.
5. Participants must be willing and able to comply with all follow-up visit requirements.
6. Participants must agree to refrain from using cosmeceutical agents or topical agents during the study, except as directed by study investigator.
7. Participants must be rated as (2) Moderate Sagging to (4) Very Severe Sagging based on the Merz Jawline Grading Scale (MJGS)[11].
8. Participants must be rated as a (C) Grade 3: moderate laxity, (D) Grade 4: moderate to severe laxity or (E) Grade 5: severe laxity of the tissues of the neck based on the 5-Grade IBSA Neck Laxity Scale [12]
9. Participants of childbearing potential must have been on an acceptable form of contraception for 30 days prior to enrollment and agree to continue using throughout the course of the study.
10. Participants agree to maintain stable body weight, defined as no planned weight-loss program and no significant change in body weight (±10 lbs or ±5%) within 3 months prior to enrollment and throughout study participation.
11. Participants identified as an appropriate candidate for study treatment based on principal investigator's opinion.

Exclusion Criteria:

1. Participants must not have active localized or systemic infections.
2. Participants must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g., lupus, scleroderma, history of keloid scar formation), atopic dermatitis or immunologic abnormalities such as vitiligo.
3. Participants must not be current smoker or have history of regular tobacco or nicotine use within 12 months prior to enrollment.
4. Participants must not have had treatments with systemic steroids or systemic retinoids in the 4-months prior to enrollment.
5. Participants must not have had treatments with 5FU, diclofenac, imiquimod or PDT within 1-month prior to enrollment.
6. Participants must not have severe or cystic facial acne; currently taking Accutane or have taken Accutane within the last 1-month.
7. Participants must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications.
8. Participants must not have had previous surgery and/or fat transfer in the treatment area within the last 6-months.
9. Participant must not have had injectable soft tissue fillers within the last 12-months in the treatment area.
10. Participant must not have had Poly-L-Lactic acid (PLLA) or Calcium Hydroxylapatite (CaHA) fillers within the last 2 years in the treatment area.
11. Participant must not have had permanent filler i.e., Polymethylmethacrylate (PMMA) in the treatment area.
12. Participants must not have had neurotoxins within the last 4-months in the treatment area.
13. Participant must not have a personal history of any facial threads i.e., PDO (Polydioxanone), PLLA (Polylactic acid), PCL (Polycaprolactone) in the treatment area within the last 12-months.
14. Participant must not have had a pulse dye or vascular laser, non-ablative laser, microneedling or RF microneedling treatments in the treatment area within the last 3-months.
15. Participant must not have had an ultrasound treatment such as HIFU, monopolar RF energy-based devices, ablative laser treatments in the treatment area within the last 6-months.
16. Participants must not have a personal history of malignant melanoma, keloid scars, generalized psoriasis or systemic diseases that would preclude the use of topical anesthesia.
17. Participant must not have active sunburn or excessively tanned skin.
18. Participants must not be pregnant or planning to become pregnant, have given birth less than 3-months ago, and/or breastfeeding during the study. Participants of childbearing potential will be asked to confirm they are not pregnant at screening, at each treatment visit and at Visit 6: Day 139 ± 7 days (3-month follow-up) representing approximately 90 days following the second treatment and Visit 7: Day 229 ± 7 days (6-month follow-up).